Minimally invasive breast lift method with a superior tissue support and an inferior anchor

ABSTRACT

Described are methods and apparatus for use in supporting tissue in a patient&#39;s body. In some embodiments, the patient&#39;s breast or another tissue is supported. One method involves introducing a superior soft tissue anchor into a patient, the anchor having an inferiorly facing total surface area; and introducing at least one inferior soft tissue anchor into the patient, such that the at least one inferior soft tissue anchor is suspended from the superior soft tissue anchor, the sum of all of the at least one inferior soft tissue anchors having a superiorly facing total surface area. The inferiorly facing total surface area of the superior anchor can be greater, such as at least two times greater than the superiorly facing total surface area of the at least one inferior anchor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. §120 as a continuationapplication of U.S. patent application Ser. No. 12/611,038 filed on Nov.2, 2009, currently pending, which claims priority under 35 U.S.C.§119(e) to U.S. Provisional Application No. 61/110,409 filed Oct. 31,2008, and also claims priority as a continuation-in-part application toPCT Application No. PCT/US2009/062879 filed on Oct. 30, 2009, which inturn claims priority to U.S. Provisional Application No. 61/110,409filed Oct. 31, 2008. All of the priority applications are herebyincorporated by reference in their entireties.

BACKGROUND

1. Field of the Invention

Embodiments of the invention are useful in the field of minimallyinvasive surgical devices and methods, and in particular, devices andmethods for use in mastopexy.

2. Description of the Related Art

Ptosis is a condition in a tissue or organ of the body in which thetissue or organ sags, or falls, with respect to its previous position inthe body. A variety of surgical and nonsurgical procedures and deviceshave been developed to restore tissues and organs to a previousposition. In particular, cosmetic surgery is frequently directed atrestoring tissues to a pre-sag position.

For example, in mastopexy, mammary ptosis is corrected using a surgicalprocedure, without altering breast volume. In augmentation, breastvolume is increased, while in reduction surgery, breast volume isdecreased. Procedures can include combinations of mastopexy andaugmentation or reduction procedures as well.

SUMMARY OF THE INVENTION

Disclosed herein is a system for performing a tissue lift. The systemcan include an elongate, flexible sling having a first end and a secondend and configured to be subcutaneously introduced along a generallymedial-lateral axis; a first suspension line carrying a first inferiorsoft tissue anchor and having a first superior free end; and a secondsuspension line carrying a second inferior soft tissue anchor and havinga second superior free end. The first superior free end can beconfigured to be connected to the first end of the sling, and the secondsuperior free end is configured to be connected to the second end of thesling. The sling can be made of any appropriate material, such as amesh, e.g., polypropylene. A suspension line could include a suture thatcould be bioabsorbable or non-bioabsorbable. The anchor could have afirst reduced configuration during delivery and an enlargedconfiguration when implanted in tissue. The anchor could, in someembodiments, include a threaded element, such as a corkscrew. The systemcould also include a needle for introducing a sling subcutaneously. Theneedle could have an arc of at about 180 or 270 degrees, or betweenabout 180-360 degrees in some embodiments. The sling and first inferiorsoft tissue anchor could be configured such that when implanted intissue, a force in an inferior direction required to pull out the slingexceeds by at least 2× the force in the superior direction to pull outthe inferior anchor. In some embodiments, the sling could have a firstsurface area that is defined as an inferiorly facing surface area, andwherein the first and second inferior anchors collectively comprise asecond surface area defined as the sum of the superiorly facing surfaceareas of the first and the second inferior anchors, wherein the firstsurface area exceeds the second surface area by at least about 1.5×, 2×,3×, 4×, 5×, 6×, 7×, 8×, 9×, 10×, or more. In some embodiments, eitherthe superior anchor, inferior anchor, or both could be free-floating intissue, that is, suspended in soft tissue as opposed to bone orcartilage. In some embodiments, the sling can be configured todistribute a load from the first and second inferior anchors over anarea of at least about 1 cm², 2 cm², 3 cm², 4 cm², 6 cm², 8 cm², 10 cm²,or more of the sling.

One embodiment of the invention includes a system or kit for performingminimally invasive mastopexy (also known as a tissue lift). Unlikeconventional mastopexy, some embodiments of the invention do not involveor substantially do not involve removal of the patient's skin in orderto create the tissue lift. The system could include an elongate flexiblesling having a first end and a second end; a first suspension linecarrying a first soft tissue anchor and a first superior free end; asecond suspension line carrying a second soft tissue anchor and a secondsuperior free end; a curved needle for creating a tissue pathway for theelongate flexible sling; an inferior anchor insertion tool for creatinga tissue pathway for an anchor along a generally superior-inferior axis;a trocar for creating a tissue pathway for a superior port; and asuperior port. The system or kit could also include other components,such as, for example, a feeder rod having a proximal end and a distalend, the rod having a loop on the proximal end. The system or kit couldalso include an adjustment mechanism, such as a spool tensioner, foradjusting tension of at least one of the first suspension line and thesecond suspension line.

Also disclosed herein is a method of performing a tissue lift, that caninclude the steps of: introducing an elongate, flexible sling, having afirst end and a second end, subcutaneously along a generallymedial-lateral axis above a breast; introducing a first suspension linealong a first generally inferior-superior axis, the first suspensionline carrying a first inferior soft tissue anchor and having a firstsuperior free end; introducing a second suspension line along a secondgenerally inferior-superior axis, the second suspension line carrying asecond inferior soft tissue anchor and having a second superior freeend; connecting the first superior free end to the first end of thesling; and connecting the second free end to the second end of thesling. Connecting the sling to the suspension line can involve knottingthe two together.

Also disclosed herein is a method of treating ptosis of a body tissue.The method could include the steps of introducing an elongate, flexiblesling, having a first end and a second end, subcutaneously along agenerally medial-lateral axis above a tissue to be treated; introducinga first suspension line along a first generally inferior-superior axis,the first suspension line carrying a first inferior soft tissue anchorand having a first superior free end; introducing a second suspensionline along a second generally inferior-superior axis, the secondsuspension line carrying a second inferior soft tissue anchor and havinga second superior free end; connecting the first superior free end tothe first end of the sling; and connecting the second free end to thesecond end of the sling.

In another embodiment, disclosed is a method of tissue suspension in apatient, that includes the steps of introducing a tissue suspensionsystem into a patient, such that the system comprises an elongate,flexible sling having a lateral aspect and a medial aspect, at least afirst suspension line extending inferiorly from the lateral aspect ofthe sling and carrying at least a first inferior soft tissue anchor, andat least a second suspension line extending inferiorly from the medialaspect of the sling and carrying at least a second inferior soft tissueanchor, wherein downward movement of tissue supported by the first andsecond inferior soft tissue anchors causes the lateral aspect and themedial aspect of the sling to move inferiorly with respect to a midpointon the sling, and causes a linear distance between at least one of thefirst and second inferior anchors and the midpoint to at leastmomentarily lengthen. The introducing step could include introducing thesling and introducing the first and second suspension lines separately.

Also disclosed herein is a method of performing a tissue lift, includingthe steps of introducing a superior, soft tissue anchor into a patient,the anchor having an inferiorly facing total surface area; andintroducing at least one inferior soft tissue anchor into the patient,such that the at least one inferior soft tissue anchor is suspended fromthe superior soft tissue anchor, the sum of all of the at least oneinferior soft tissue anchors having a superiorly facing total surfacearea. The inferiorly facing total surface area of the superior anchorcan be at least 2, 3, 4, 5, 6, 7, 8, 9, 10, or more times greater thanthe superiorly facing total surface area of the at least one inferioranchor.

Embodiments disclosed herein are directed to minimally invasive methodsand apparatus of tissue support. In some embodiments, there is provideda device, for use in supporting a tissue in a patient's body,comprising; a support member, adapted to engage at least a portion of atissue, the support member comprising a first end and a second end, thesupport member further comprising a plurality of support elements; andfirst and second suspension members, the first suspension member beingcoupled to the first end of the support member, the second suspensionmember being coupled to the second end of the support member; wherein atleast one of the first and second suspension members is configured to besecured to a location in the patient's body; wherein the plurality ofsupport elements is configured to distribute a load, from the tissueengaged by the support member, imposed on the support member; andwherein at least one of the first and second suspension members isconfigured to transmit a force through the support member, the forceeffective to move the engaged portion of the tissue from a firstposition to a second position.

In some embodiments, the first suspension member is coupled to eachsupport element at a first end of each support element, and the secondsuspension member is coupled to each support element at a second end ofeach support element.

In some embodiments, the second position is superior to the firstposition. In some embodiments, the second position is at least one ofposterior, medial, and lateral, relative to the first position. In someembodiments, the second position is posterior to the first position.

In some embodiments, each of the plurality of support elements iselongate and has a length extending along an arc, or line, that extendsbetween the first end of the support member and the second end of thesupport member; wherein a first of the plurality of support elements isspaced apart from a second of the plurality of support elements along atleast about 10% of a length of the first of the plurality of supportelements; and wherein the length of the plurality of support elementsextends from the first end of the support member to the second end ofthe support member.

In some embodiments, a first of the plurality of support elements isspaced apart from a second of the plurality of support elements along atleast about 30% of a length of the first of the plurality of supportelements; and wherein the length of the plurality of support elementsextends from the first end of the support member to the second end ofthe support member.

In some embodiments, at least one of the support elements is fusiformshaped.

In some embodiments, at least one suspension member is configured to besecured to at least one of muscle, fascia, bone, ligament, tendon, andskin. In some embodiments, the portion of the tissue being engagedcomprises at least one of breast tissue, buttock tissue, facial tissue,arm tissue, abdominal tissue, and leg tissue.

In some embodiments, each support element comprises at least one of anelongate member and a mesh.

In some embodiments, each of the plurality of support elements iscoupled to a separator, effective to maintain spacing between adjacentsupport elements.

In some embodiments, the support member comprises an engagement member,effective to limit movement of the support member relative to theengaged portion of the tissue. In some embodiments, the engagementmember comprises at least one of a barb, a hook, and a suture.

In some embodiments, at least a portion of the device comprises abiodegradable material. In some embodiments, the device furthercomprises a coating effective to enhance at least one ofbiocompatibility and healing. Further, the device could be used as awound closure device or trauma device, in which some applications wouldwarrant a full biodegradable device. Other instances would warrantpartial biodegradable devices. And yet other instances, a durable devicewould be desirable.

In some embodiments, there is provided a device, for use in supporting atissue in a patient's body, comprising; a support member, adapted toengage at least a portion of a tissue, the support member comprising afirst end, a second end, and an inflatable portion therebetween;wherein, upon inflation, the inflatable portion is effective to increasean apparent volume of the tissue; first and second suspension members,the first suspension member being coupled to the first end of thesupport member, and the second suspension member being coupled to thesecond end of the support member; wherein at least one of the first andsecond suspension members is configured to be secured to a location inthe patient's body; wherein the support member is configured todistribute a load imposed on the support member from the tissue engagedby the support member; and wherein at least one of the first and secondsuspension members is configured to transmit a force through the supportmember, the force effective to move the engaged portion of the tissuefrom a first position to a second position.

In some embodiments, the second position is superior to the firstposition. In some embodiments, the second position is at least one ofposterior, medial, and lateral, relative to the first position. In someembodiments, the second position is inferior to the first position, andin some embodiments, the second position is at least one of posterior,medial, and lateral, relative to the first position.

In some embodiments, the tissue being supported comprises at least oneof breast tissue, buttock tissue, facial tissue, arm tissue, abdominaltissue, and leg tissue.

In some embodiments, the inflatable portion comprises pleats. In someembodiments, the device further comprises a port for inflating theinflatable portion. In some embodiments, the port is in or on at leastone of the suspension members.

In some embodiments, there is provided a device, for use in supportingtissue, comprising; a support member, adapted to engage at least aportion of a tissue, the support member comprising a first end and asecond end; wherein the support member is configured to distribute aload imposed on the support member from the tissue engaged by thesupport member; and first and second suspension members, the firstsuspension member being coupled to the first end of the support memberand the second suspension member being coupled to the second end of thesupport member; wherein at least one suspension member is configured tobe secured to a location at least about 5 cm away from the engagedportion of the tissue; wherein at least one of the first suspensionmember, the second suspension member, and the support member comprisesan elastic element; wherein at least one of the first and secondsuspension members is configured to transmit a force through the supportmember, the force effective to move the engaged portion of the tissuefrom a first position to a second position; and wherein the elasticelement is configured to permit movement of the engaged portion of thetissue from the second position toward the first position.

In some embodiments, the second position is superior to the firstposition. In some embodiments, the second position is at least one ofposterior, medial, and lateral, relative to the first position.

In some embodiments, the portion of the tissue being engaged comprisesat least one of breast tissue, buttock tissue, facial tissue, armtissue, abdominal tissue, and leg tissue.

In some embodiments, the elastic element comprises at least one of anelastomeric core and an elastomeric cover. In some embodiments, theelastic element comprises a spring.

In some embodiments, the at least one suspension member comprises abraided portion. In some embodiments, at least a portion of the elasticelement has a nonlinear elastic constant.

In some embodiments, the device further comprises a channel memberthrough which at least a portion of a suspension member passes, when thedevice is implanted in the body; wherein the channel member isconfigured to limit contact of surrounding tissue by the portion of thesuspension member. In some embodiments, the channel member is tubular.

In some embodiments, there is provided a device, for use in supporting atissue in a patient's body, comprising; a support member, adapted toengage at least a portion of a tissue, the support member comprising afirst end and a second end; wherein the support member is configured todistribute a load imposed on the support member from the tissue engagedby the support member; first and second suspension members, the firstsuspension member being coupled to the first end of the support member,and the second suspension member being coupled to the second end of thesupport member; and a disconnect member, configured to release tensionin the suspension member when a load on the device exceeds a thresholdload; wherein at least one of the suspension members is configured to besecured to a location in the patient's body; and wherein at least one ofthe suspension members is configured to transmit a force through thesupport member, the force effective to move an engaged portion of thetissue of the patient from a first position to a second position.

In some embodiments, the second position is superior to the firstposition. In some embodiments, the second position is at least one ofposterior, medial, and lateral, relative to the first position. In someembodiments, the portion of the tissue being engaged comprises at leastone of breast tissue, buttock tissue, facial tissue, arm tissue,abdominal tissue, and leg tissue.

In some embodiments, the disconnect member is configured to separate afirst portion of at least one of the suspension members from a secondportion of the at least one of the suspension members in response to theload that exceeds the threshold. In some embodiments, the disconnectmember is configured to separate at least one of the suspension membersfrom the support member in response to the load that exceeds thethreshold.

In some embodiments, there is provided a device, for use in supporting atissue in a patient's body, comprising: an elongate suspension member,having a first end and a second end, and a length extendingtherebetween; wherein the suspension member is configured to engage, andexert traction on, a tissue, resulting in the tissue moving from a firstposition to a second position; wherein at least a portion of suspensionmember is configured to shorten along the length of the suspensionmember in response to delivery of an energy to the suspension member;wherein the suspension member further comprises at least one engagementmember, configured to engage at least a portion of the tissue; anelongate energy delivery member, coupled to at least a portion of thesuspension member; wherein at least a portion of the elongate energydelivery member extends alongside at least a portion of the length ofthe suspension member; and wherein the elongate energy delivery memberis configured to deliver the energy to the suspension member.

In some embodiments, the energy comprises at least one ofelectromagnetic energy, acoustic energy, and thermal energy. In someembodiments, the at least a portion of the elongate suspension membercomprises collagen. In some embodiments, the at least a portion of theelongate suspension member comprises at least one of a shape memoryalloy and a shape memory polymer. In some embodiments, the at least aportion of the elongate suspension member comprises a swellablematerial. In some embodiments, the swellable material comprises ahydrogel. In some embodiments, the at least a portion of the elongatesuspension member comprises a braid.

In some embodiments, there is provided a method, for supporting a breastin a body of a patient, comprising: providing a supporting device havinga first end, a second end, and a support member positioned between thefirst end and second end; advancing the first end of the supportingdevice into a breast, through a first incision that is located on one ofa medial and a lateral side of the breast; withdrawing the first end ofthe supporting device from the breast through a second incision, locatedon the other of the medial and the lateral side of the breast, until thesupport member is positioned within breast tissue between the firstincision and second incision; advancing the first end of the supportingdevice, from a position within the breast adjacent the second incision,to a first location, and the second end of the supporting device, from aposition within the breast adjacent the first incision, to a secondlocation; wherein both of the first and second locations are superior tothe first and second incisions; drawing the breast tissue toward thefirst and second locations; and anchoring the first and second ends ofthe supporting device at the first and second locations, respectively.

In some embodiments, the first and second locations are substantiallythe same location.

In some embodiments, the method further comprises coupling a portion ofthe first end to a portion of the second end, inside the body. In someembodiments, anchoring comprises coupling the first and second ends toat least one of bone, muscle, fascia, tendon, ligament, and skin.

In some embodiments, there is provided a method, for supporting a tissuein a body of a patient, comprising: placing a supporting device into thebody, the supporting device comprising: a support member, adapted toengage at least a portion of a tissue, the support member comprising afirst end and a second end; wherein the support member is configured todistribute a load imposed on the support member from the tissue engagedby the support member; at least one suspension member coupled to thesupport member; engaging the at least a portion of the tissue with thesupport member; applying tension to the at least one suspension member,thereby moving the engaged portion of the tissue from a first positionto a second position; securing the at least one suspension member to alocation in the body, such that the engaged portion of the tissue iseffectively maintained in the second position; and inflating at least aportion of the supporting device to increase an apparent volume of thetissue.

In some embodiments, the portion of the tissue being engaged comprisesat least one of breast tissue, buttock tissue, facial tissue, armtissue, abdominal tissue, and leg tissue.

In some embodiments, there is provided a method, for supporting a tissuein a body of a patient, comprising: placing a supporting device into thebody, the supporting device comprising: a support member, adapted toengage at least portion of a tissue, the support member comprising afirst end and a second end; wherein the support member is configured todistribute a load imposed on the support member from the tissue engagedby the support member; and at least one suspension member coupled to thesupport member; placing the support member so as to effectively engageat least a portion of the tissue; applying tension to the at least onesuspension member, thereby moving the engaged portion of the tissue froma first position to a second position; securing the at least onesuspension member to a location in the body, such that the engagedportion of the tissue is effectively maintained substantially in thesecond position; and wherein the supporting device is configured, inresponse to a load that exceeds a threshold, to release tension in theat least one suspension member.

In some embodiments, the supporting device is configured to uncouple afirst portion of at least one of the suspension members from a secondportion of the at least one of the suspension members in response to theload that exceeds the threshold. In some embodiments, the supportingdevice is configured to uncouple at least one of the suspension membersfrom the support member in response to the load that exceeds thethreshold. In some embodiments, the at least one suspension memberincreases in length when the load exceeds the threshold.

In some embodiments, there is provided a method for use in supportingbreast tissue in a patient's body, comprising: providing a supportmember, adapted to engage breast tissue, the support member comprising afirst end and a second end; wherein the support member is configured todistribute a load imposed on the support member from the breast tissueengaged by the support member; and providing first and second suspensionmembers, the first suspension member being coupled to the first end ofthe support member and the second suspension member being coupled to thesecond end of the support member; wherein, when implanted, the firstsuspension member, extends superiorly from the first end of the supportmember, and the second suspension member, extends superiorly from thesecond end of the support member; anchoring the first suspension memberat a first location, and the second suspension member at a secondlocation; wherein the first and second locations are located superiorlyto the engaged breast tissue; wherein a distance between the first andsecond locations is greater than a greatest distance between the firstand second ends of the support member.

In some embodiments, there is provided a method, for use in supporting atissue in a patient's body, comprising: providing an elongate suspensionmember, having a first end and a second end, and a length extendingtherebetween; wherein the suspension member is configured to engage, andexert traction on, a tissue, resulting in the tissue moving from a firstposition to a second position; wherein at least a portion of suspensionmember is configured to shorten along the length of the suspensionmember in response to delivery of an energy to the suspension member;wherein the suspension member further comprises at least one engagementmember, configured to engage at least a portion of the tissue; providingan elongate energy delivery member, coupled to at least a portion of thesuspension member; wherein at least a portion of the energy deliverymember extends alongside at least a portion of the length of thesuspension member; and wherein the energy delivery member is configuredto deliver the energy to the suspension member; delivering the energy tothe energy delivery member, thereby shortening the suspension member. Insome embodiments, delivering energy comprises delivering at least one ofelectromagnetic energy, acoustic energy, and thermal energy.

Some embodiments describe a device including an elongate member and aplurality of side members, each of which has a first end and a secondend. In some embodiments, each of the plurality of side members beingcoupled to, or integral with, the elongate member at the first end. Insome embodiments, each of the plurality of side members subtending anacute angle with respect to the elongate member when the device is in anexpanded state. Some embodiments provide that advancement of the devicein a first direction results in a securing of the device in a tissue. Incertain embodiments, after the securing, advancement of the device in asecond direction, opposite the first direction, through the tissueresults in the device changing from the expanded state to a collapsedstate as the second end of each of the plurality of side members movescloser to the elongate member, permitting passage of the device throughthe tissue in the second direction.

In some embodiments, the device includes an elongate member having alumen passing therethrough, the elongate member configured to hold thedevice when the device is in the collapsed state, for delivery of thedevice into the tissue.

Some embodiments describe a device, for use in supporting a tissue in apatient's body, including a support member, adapted to engage at least aportion of a tissue, the support member comprising a first portion and asecond portion; and first and second suspension members, the firstsuspension member coupled to, and movable with respect to, the firstportion of the support member, the second suspension member coupled to,and movable with respect to, the second portion of the support member.In some embodiments, at least one of the first and second suspensionmembers is configured to be secured to a location in the patient's body.In some embodiments, at least one of the first and second suspensionmembers is configured to transmit a force through the support member,the force effective to move the engaged portion of the tissue from afirst position to a second position.

In some embodiments, the first suspension member is slidable withrespect to the first portion of the support member, and the secondsuspension member is slidable with respect to the second portion of thesupport member. In some embodiments, the device further includes ananchor member coupled to, or integral with, at least one of the firstand second suspension members.

In some embodiments, the anchor member includes an elongate member and aplurality of side members, each of which has a first end and a secondend; each of the plurality of side members being coupled to, or integralwith, the elongate member at the first end; and each of the plurality ofside members subtending an acute angle with respect to the elongatemember when the anchor member is in an expanded state. In someembodiments, advancement of the anchor member in a first directionresults in a securing of the anchor member in a tissue. In someembodiments, after the securing, advancement of the anchor member in asecond direction, opposite the first direction, through the tissueresults in the anchor member changing from the expanded state to acollapsed state as the second end of each of the plurality of sidemembers moves closer to the elongate member, permitting passage of theanchor member through the tissue in the second direction. In someembodiments, the anchor member comprises at least one of a hook, a dart,a barb, and a clasp.

Some embodiments provide minimally invasive methods, for elevating softtissue in a body, that include providing a supporting device, comprisinga first portion, a second portion, and a support member positionedbetween the first portion and second portion; advancing the firstportion of the supporting device into the body, through a singleincision, to a first location in the body; advancing the second portionof the supporting device into the body, through the incision, to asecond location in the body; securing the first portion of thesupporting device at the first location; and shifting soft tissue in thebody with the support member.

In some embodiments, the shifting comprises elevating the soft tissuesuperiorly. In some embodiments, both of the first and second locationsare located superior to the incision. In some embodiments, at least oneof the first and second locations is located superior to the incision.In some embodiments, the method further includes drawing the soft tissuetoward at least one of the first and second locations.

Some embodiments provide that the soft tissue comprises breast tissue.In some embodiments, the first and second locations are substantiallythe same location. In some embodiments, at least one of the first andsecond locations is at a fascia. In some embodiments, at least one ofthe first and second locations is at a muscle. In some embodiments, atleast one of the first and second locations is at a clavicle. In someembodiments, at least one of the first and second locations is at a rib.In some embodiments, the securing comprises suturing the first portion.In some embodiments, the securing comprises positioning an anchoringmember at the first location. In some embodiments, the anchoring membercomprises at least one of a hook, a dart, a barb, and a clasp. In someembodiments, securing the second portion of the supporting device at thesecond location.

In some embodiments, the incision is made during a first time period,and the first and second portions are secured during a second timeperiod, and no additional incision is made in the body between the firstand second time periods, and no additional incision is made in the bodyduring the second time period. In some embodiments, a distance betweenthe first and second locations is greater than a longest dimension ofthe support member. In some embodiments, the first and second portionscomprise suspension elements. In some embodiments, the incision is nogreater than about 1.0 centimeter in length. In some embodiments, theincision is no greater than about 0.5 centimeters in length. In someembodiments, the incision is substantially parasagittal in orientation.In some embodiments, the incision is transverse to a long axis of thebody.

Some embodiments provide methods, of dissecting breast tissue, includinginserting a distal end of an elongate member into one of a medial and alateral aspect of a breast; after the inserting, advancing the distalend inferiorly within the breast; and after the advancing the distal endinferiorly, advancing the distal end superiorly within the breast to theother of the medial and lateral aspect, and then out of the breast, suchthat the distal end and a proximal end of the elongate member areoutside the breast and a central portion of the elongate member, betweenthe distal end and the proximal end, is within the breast.

In some embodiments, the advancing the distal end inferiorly comprisesadvancing the distal end to a point inferior to the areola of thebreast. In some embodiments, the advancing the distal end inferiorlycomprises dissecting breast tissue. In some embodiments, the elongatemember comprises a needle. In some embodiments, the elongate member isarcuate. In some embodiments, the elongate member comprises a sheath. Insome embodiments, the distal end is sharp. In some embodiments, themethod further includes advancing a support member along the elongatemember. In some embodiments, the method further includes shifting breasttissue with the support member. In some embodiments, the method furtherincludes creating a channel in the breast tissue that extends from apoint at which the elongate member is inserted into the breast; andexpanding a cross-sectional dimension of the channel. In someembodiments, the expanding the cross-sectional dimension of the channelcomprises expanding an expandable member within the channel. In someembodiments, the expandable member comprises distal end having apolygonal structure. In some embodiments, the polygonal structurecomprises a quadrilateral.

Some embodiments describe methods, for elevating soft tissue in a body,including advancing a supporting device into an incision in the body ata first location superior to the soft tissue; advancing a plurality ofanchor members inferiorly, from the first location, to a second locationwithin the soft tissue; and with at least one of the plurality of anchormembers, elevating the soft tissue superiorly toward the supportingdevice, thereby decreasing a length between the first location and thesecond location.

In some embodiments, the soft tissue comprises a breast. In someembodiments, the first location is superior to an areola of the breast.Some embodiments further include securing the plurality of anchormembers with the supporting device after the plurality of anchor membersare advanced to the second location. Some embodiments further includeadvancing a distal portion of one or more of the plurality of anchormembers through one or more openings in the soft tissue inferior to thefirst location. Some embodiments further include advancing one or moreof the plurality of anchor members entirely through the one or moreopenings and out of the body.

In some embodiments, advancing the plurality of anchor members comprisesadvancing an anchor within a sheath inferiorly from the first location.Some embodiments further include engaging the soft tissue with an anchormember by removing the sheath. In certain embodiments, advancing theplurality of anchor members comprises advancing a sheath inferiorly fromthe first location. Some embodiments further include advancing an anchorinferiorly through the sheath and engaging the tissue with the anchor byremoving the sheath.

In certain embodiments, advancing the plurality of anchors membersincludes advancing an anchor inferiorly into the soft tissue to a thirdlocation; removing the anchor from the soft tissue; and after removingthe anchor from the soft tissue, advancing the anchor inferiorly intothe soft tissue to the second location. Some embodiments includesecuring the support device to one of fascia, clavicle, rib, and muscle.

Some methods described herein, for elevating a patient's breast, includeinserting into the breast a supporting device at a first locationsuperior to the areola of the breast; and drawing breast tissue,inferior to the first location, superiorly toward the supporting deviceby decreasing a length of one or more anchoring members extendinginferiorly from the supporting device.

Some embodiments further include securing the one or more anchoringmembers with the supporting device after the drawing breast tissue. Someembodiments further include advancing a distal portion of the one ormore anchoring members through one or more openings inferior to theareola. Some embodiments further include advancing the one or moreanchoring members entirely through the one or more openings. Someembodiments further include advancing the one or more anchoring memberswithin a sheath inferiorly from the first location. Some embodimentsfurther include engaging breast tissue with an anchor by removing thesheath and retaining the anchor within the breast tissue.

Some embodiments also include advancing an anchor member inferiorly to asecond location within breast tissue; removing the anchor member fromthe breast tissue; and after removing the anchor member from the breasttissue, advancing the anchor member inferiorly to a third locationwithin breast tissue.

Some embodiments described herein related to a device, for adjustingsoft tissue in a body, having a supporting member that is configured tobe implanted in the body at a location superior to the soft tissue, thesupporting member having a first portion and a second portion; aplurality of anchor members coupled to the supporting member andconfigured to be implanted in the body at respective locations inferiorto the supporting member; wherein, when the device is implanted withinthe body, elevation of at least one of the plurality of anchor memberselevates the soft tissue, thereby bringing one or more of the pluralityof anchor members closer to the supporting member.

For purposes of summarizing the disclosure, certain aspects, advantages,and novel features of the disclosure have been described herein. It isto be understood that not necessarily all such advantages may beachieved in accordance with any particular embodiment of the disclosure.Thus, the disclosure may be embodied or carried out in a manner thatachieves or optimizes one advantage or group of advantages as taughtherein without necessarily achieving other advantages as may be taughtor suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

A general architecture that implements various features of thedisclosure will now be described with reference to the drawings. Thedrawings and the associated descriptions are provided to illustrateembodiments of the disclosure and not to limit the scope of thedisclosure. Throughout the drawings, reference numbers are re-used toindicate correspondence between referenced elements.

FIG. 1 illustrates an embodiment of a suture with molded barbs.

FIG. 2A illustrates an embodiment of a suture with a filamentous coreand a braided portion.

FIG. 2B illustrates an embodiment of a suture like that shown in FIG.2A, where filaments extend outward to form barbs.

FIG. 3 illustrates an embodiment of a suture with a separately attachedbarb element.

FIG. 4 illustrates the stress strain relationship among various suturetypes.

FIG. 5A illustrates an embodiment of a braided suture.

FIG. 5B illustrates an embodiment of the suture shown in FIG. 5A, withthe braided portion removed to reveal the core.

FIG. 6A is a cross-sectional view of an embodiment of a braided suturethat includes a membrane lying between the braid and the suture core.

FIG. 6B is a side view of the suture illustrated in FIG. 6A.

FIG. 7A is a cross-sectional view of an embodiment of a braided sutureimpregnated with an elastomeric coating.

FIG. 7B is a perspective view of the suture illustrated in FIG. 7A.

FIG. 8A illustrates an embodiment of a braided suture with a hydrogelcore in a pre-activation (elongated) configuration.

FIG. 8B illustrates an embodiment of a braided suture with a hydrogelcore in a post-activation (shortened) configuration.

FIG. 9 illustrates an embodiment of a suture in which shortening of thesuture is provided by a shape memory material.

FIG. 10A is a cross-sectional view of an embodiment of a suture having awidened portion to spread out loading and limit cheese wiring of thesuture through tissue.

FIG. 10B is a side view of the suture shown in FIG. 10A.

FIG. 11A illustrates side view of an embodiment of a suture having awidened portion to spread out loading in an extended conformation, wherethe widened portion is expandable.

FIG. 11B illustrates a suture like that shown in FIG. 11A that has beenrolled up for delivery.

FIG. 11C illustrates an end view of suture like that shown in FIG. 11Athat has been expanded.

FIG. 11D illustrates an end view of a suture like that shown in FIG. 11Athat has been expanded and then flattened.

FIG. 12A illustrates side view of an embodiment of a suture having awidened portion, and further comprising support members.

FIG. 12B illustrates a suture like that shown in FIG. 12 that has beenrolled up for delivery.

FIG. 12C illustrates a cross-sectional view of a suture like that shownin FIG. 12 that has been expanded.

FIG. 12D illustrates an end view suture like that shown in FIG. 11A thathas been expanded and then flattened.

FIG. 13A illustrates a perspective view of a suture with a braidedregion that shortens and widens when attached sutures are placed undertension, in an extended conformation.

FIG. 13B illustrates a perspective view of a suture like that shown inFIG. 13A in the shortened conformation

FIG. 14A is a cross-sectional view of a suture with a flat supportregion rolled into a circular cross-section for easy placement in thepatient.

FIG. 14B is a side view of the suture shown in FIG. 14A.

FIG. 15A is a cross-sectional view of a suture with a support regioncomprising multiple strands that provide tissue support.

FIG. 15B is a side view of the suture shown in FIG. 15A.

FIG. 16A illustrates a needle and sheath arrangement for use indelivering a suture.

FIG. 16B illustrates a suture having bidirectionally oriented barbs.

FIG. 16C illustrates a sheathed suture with barbs to engage tissue toassist in deployment.

FIG. 16D illustrates the suture of FIG. 16C with an end extended fromthe sheath as during deployment.

FIG. 16E illustrates an embodiment of a sheathed suture and deploymentsheath where the end of the suture can be bent backwards as part of themethod of deployment.

FIG. 16F illustrates an embodiment of a sheathed suture where deploymentis aided by a pushable tube.

FIG. 17 A illustrates an embodiment of a curved needle for use indeploying a suture along a curved path.

FIG. 17B illustrates a tube configured to hold a needle, and which has alarger radius of curvature than the needle of FIG. 17A.

FIG. 17C illustrates a coaxial needle combination where the tip of theinner needle is pulled back from the end of the outer needle.

FIG. 17D illustrates a coaxial needle combination where the tip of theinner needle is inserted nearly to the end of the outer needle.

FIG. 18 illustrates an embodiment of a device for deploying andtensioning a suture, as well as for connecting suture ends.

FIG. 19 is a side view illustrating a placement of sutures to perform abreast lifting procedure.

FIG. 20 is a front view illustrating a placement of sutures to perform abreast lift procedure.

FIG. 21 is a side view of a breast and an embodiment of a support systemcomprising a support member and vertically oriented suspension members.

FIG. 22 is a side view of a breast and an embodiment of a support systemcomprising a support member and suspension members oriented verticallyand non-vertically.

FIG. 23 is a side view of a breast and an embodiment of a support systemcomprising two types of elastomeric components, and a safety mechanismto prevent overloading of the tissue.

FIG. 24 is a side view of a breast and an embodiment of a support systemcomprising continuous length suspension members, and a length adjustmentmechanism.

FIG. 25 is a side view of a breast and an embodiment of a support systemwhere the support member comprises inflation chambers.

FIG. 26 is a side view of a breast and an embodiment of a tool forinserting and spreading or flattening a support member in the tissue.

FIG. 27 is a side view of a breast and an embodiment of a support membercomprising barbs.

FIG. 28 is a side view of a breast and an embodiment of a support systemcomprising a nipple repositioning element.

FIG. 29A is an embodiment of a support member, associated suspensionmembers, and needles for insertion.

FIG. 29B is a photograph of an embodiment of a support member andattached suspension member.

FIG. 30 illustrates an embodiment of a support system including channelsfor the suspension members, and spring elements.

FIG. 31 illustrates an embodiment of a support system comprisingseparators to maintain spacing between adjacent support members.

FIG. 32A-B illustrate an embodiment of a support system including anadditional structural support member.

FIGS. 33A-33F illustrates a method of surgical placement of anembodiment in a breast lift procedure.

FIG. 34A-34B illustrates the use of an embodiment of a suture to performa neck lift procedure.

FIG. 35 illustrates the use of an embodiment of a suture to perform anabdominal wall tightening procedure.

FIG. 36A-36B illustrates the use of an embodiment of a suture to performa facelift procedure.

FIGS. 37A-37B depict embodiments of an needle that can be used as aguide.

FIGS. 38A-38D depict embodiments of needles that can be used to create adissecting plane.

FIGS. 39A-39C depict embodiments of dissecting needles that are used inconjunction with an implantable sling.

FIGS. 40A-40D depict embodiments for dissecting tissue or creating adissecting plane.

FIGS. 41A-41B depict embodiments of a retractable dissector.

FIGS. 42A-42F depict embodiments of a conforming sheath that isconfigured to create a dissecting plane.

FIGS. 43A-43C depict embodiments of a safety suture loop installer.

FIGS. 44A-44B depict embodiments of a depth gauge introducer.

FIGS. 45A-45C depict embodiments of an expandable sling guide.

FIGS. 46A-46B depict embodiments of a retracting “diamond” dissector.

FIGS. 47A-47B depict embodiments of a retracting “diamond” dissectorwith sling mount.

FIGS. 48A-48B depict embodiments of a retracting dissector with sheathcontrol.

FIGS. 49A-49B depict embodiments of a self-dissecting sling.

FIGS. 50A-50B depict embodiments of needles that are used in conjunctionwith a dissecting tool and a sling.

FIGS. 51A-51B depict embodiments of a needle having bistableconfigurations.

FIG. 52 depicts embodiments of a detectable sling-suture connector.

FIGS. 53A-53B depict embodiments of sling exit points for procedures asdescribed herein.

FIGS. 54A-54C depict embodiments of a variable length port.

FIGS. 55A-55C depict embodiments of a suture clamp.

FIGS. 56A-56B depict embodiments of a hooked slide.

FIG. 57 depicts embodiments of a multiple dart suture.

FIGS. 58A-58D depict embodiments of an anchor clasp.

FIGS. 59A-59B depict embodiments of zip tie sling closures.

FIGS. 60A-60C depict embodiments of zip tie sling closures.

FIGS. 61A-61B depict embodiments of friction fit anchor.

FIG. 62 depicts embodiments of an anchor spring.

FIGS. 63A-63C depict embodiments of an anchor spring device.

FIG. 63D depicts embodiments of a sling weave anchor spring device.

FIG. 64 depicts embodiments of a double anchor spring.

FIGS. 65A-65E depict embodiments of a barbed anchor release device.

FIGS. 66A-66B depict embodiments of a key hole anchor.

FIGS. 67A-67B depict embodiments of a “V”-shaped anchor.

FIGS. 68A-68B depict embodiments of a tongue depressor anchor.

FIGS. 69A-69F depict embodiments of a wall anchor used in connectionwith the systems and methods described herein.

FIG. 70 depicts embodiments of a suture in-weave anchor.

FIG. 71 depicts embodiments of a hybrid anchor.

FIGS. 72A-72B depict embodiments of a trap anchor.

FIGS. 73A-73B depict embodiments of a bent barbed anchor.

FIGS. 74A-74B depict embodiments of a barbed plate.

FIGS. 75A-75B depict embodiments of a barbed plate.

FIGS. 76A-76B depict embodiments of a staple anchor.

FIGS. 77A-77B depict embodiments of a staple anchor.

FIGS. 78A-78E depict embodiments of a staple anchor deployment device.

FIG. 79 depicts embodiments of a supraareolar device.

FIG. 80 depicts embodiments of a sling positioning procedure.

FIG. 81 depicts embodiments of a belt buckle securing device.

FIG. 82 depicts embodiments of an angled anchor deployment.

FIGS. 83A-83B depict embodiments of profiled springs.

FIGS. 84A-84B depict embodiments of profiled springs.

FIGS. 85A-85B depict embodiments of profiled springs.

FIGS. 86A-86C depict embodiments of an interrupted lumen.

FIGS. 87A-87C depict embodiments of an attached lumen delivery system.

FIG. 88 depicts embodiments of a tubular spring.

FIGS. 89A-89C depict embodiments of a slide sheath deployment system.

FIGS. 90A-90B depict embodiments of a corkscrew deployment device.

FIG. 90C depicts embodiments of a corkscrew plate.

FIG. 91 depicts embodiments of a barbed multifilament suture.

FIG. 92 depicts embodiments of an umbrella suture.

FIG. 93 depicts embodiments of an advancing corkscrew.

FIGS. 94A-94B depict embodiments of a hanger anchor.

FIG. 95 depicts embodiments of a braid overlay corkscrew.

FIG. 96 depicts embodiments of a leaf anchor.

FIG. 97 depicts embodiments of an umbrella anchor.

FIGS. 98A-98B depict embodiments of a washer anchor.

FIG. 99 depicts embodiments of a T-bar anchor support.

FIG. 100 depicts embodiments of a fascia puncture deployment system.

FIG. 101 schematically depicts an embodiment of a tissue anchor.

FIGS. 102A-102D depict embodiments of a tissue anchor described herein.

FIGS. 103A-103S depict embodiments of introducing tissue supports into apatient.

FIGS. 104A-104H depict embodiments of introducing tissue supports into apatient.

FIGS. 105A-105J depict embodiments of introducing tissue supports into apatient.

FIGS. 106 and 107 schematically illustrate components of one embodimentof a mastopexy installation system.

FIG. 108 illustrates manufacturing steps for making a tissue anchor,according to one embodiment of the invention.

FIG. 109A-G illustrate embodiments of tissue anchors with variousapertures and/or reinforcing elements, according to some embodiments.

FIGS. 110A-110C and FIG. 111 illustrate a process of attaching an anchorto a suture line, according to some embodiments of the invention.

FIG. 112 illustrates a process of attaching the support sling to asuture line, according to one embodiment of the invention.

FIGS. 113A-C illustrate additional anchor configurations, according tosome embodiments of the invention.

FIGS. 114A-E illustrate various views of complementary elements of ananchor, according to some embodiments of the invention.

FIG. 115 illustrates a radially expandable anchor, according to oneembodiment of the invention.

FIG. 116 illustrates a threadable anchor, according to one embodiment ofthe invention.

FIG. 117 illustrates a corkscrew-type anchor, according to oneembodiment of the invention.

FIGS. 118-119 illustrate an interrelationship between an anchor and asuture line as tension is applied.

FIGS. 120-122 illustrate reduced and enlarged configurations of anchors,according to some embodiments of the invention.

FIG. 123 illustrate various arc configurations for a sling insertionneedle, according to one embodiment of the invention.

FIGS. 124A-J illustrate steps and components of a mastopexy procedurefor tensioning, securement, and adjustment, according to one embodimentof the invention.

FIGS. 125A-E illustrate a spool tensioning system for tensioning asuture line in situ, according to one embodiment of the invention.

FIGS. 126A-D illustrate a hook tool for capturing a suture line forretensioning, according to some embodiments of the invention.

FIGS. 127A-D illustrate a tension adjustment procedure followinginstallation of a mastopexy system, according to one embodiment of theinvention.

FIGS. 128A-D illustrate an alternative tension adjustment procedure.

FIGS. 129A-D illustrate various embodiments of implants with one or morepositioning tabs.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

As used herein, the term “suture” is to be construed broadly. Ingeneral, the term “suture” refers to suspension members, while “supportsystem” generally refers to complex, multi-component devices that caninclude, without limitation, at least one support member, and associatedcomponents such as suspension members, elastic elements, safetymechanisms, and anchoring portions. A support member can comprise, insome embodiments, a plurality of support elements.

In some embodiments, a suture 10 comprising barbs 20 is provided, asshown in FIG. 1. In some embodiments, the core 30 has a relatively hightensile strength. High tensile strength can be achieved by using apolymeric material in a manufacturing process that results in astructure where the polymer chains are substantially oriented parallelto the longitudinal axis of the suture.

The core 30 of the suture 10 can be partially or completely surroundedby a like, or different material, forming the barbs 20. The propertiesof the suture materials can be selected on the basis of desiredabsorption rates, tissue in-growth, as well as a consideration ofmechanical needs.

In some embodiments, the suture 10 is formed by extruding the corematerial to form a filament. The core 30 can then be placed in a moldthat provides the barb shapes, and the mold cavity filled with materialthat when solid forms the outer layer of the suture, and the barbs 20.

In some embodiments, the core 30 can comprise multiple filaments 33, asshown in FIG. 2A. A multiple filament design allows the suture 10 toattain a higher ratio of axial tensile strength compared to bendingstiffness (i.e., resistance to bending). A portion of the filaments 33can protrude, as shown in FIG. 2B. These protruding filaments can extenda pre-determined distance, for example between about 0.2 and 2 mm. Insome embodiments, the ends of the protruding filaments are configured inthe shape of barbs 20. The suture can be coated with another material orcan be left uncoated.

In some embodiments of a suture 10, like that shown in FIG. 3, barbs 50can be attached to the core 30 as separate members. These attached barbs50 can be secured by bonding, gluing, or welding of the barb 50 to theouter surface of the suture core 30.

Elastic Properties

In conventional suture designs, an elastic suture typically displaysonly modest extensibility. Ideally, an elastic suture used in securing ahealing wound should have sufficient elasticity to accommodate theswelling of tissue that occurs as part of the normal inflammatoryresponse at the onset of healing. Additionally, the suture shouldcontinue to provide support to the tissue or wound, once inflammationand swelling have substantially subsided.

When sutures are used to support tissue, as in plastic surgeryprocedures, different elastic properties may be desirable. For example,during the first part of the healing process, it is possible for thesutures to pull out from the tissue in response to a modest amount oflongitudinally applied force. Thus, a more elastic suture can yieldenough to prevent pull-out, yet recover to its initial length, thusproviding a gradual and more effective remodeling of tissue over time.

In some embodiments, a suture designed for use in plastic surgeryprocedures, for example in a facelift procedure, is capable of extendingin length to 10-25%, while retaining the ability to fully recover tosubstantially its initial length. An example of the stress-strain curvesfor various types of sutures is provided in FIG. 4. Embodiments of thepresent disclosure (FIG. 4, dotted line), sutures are able toaccommodate significant strain while displaying less stress thantraditional high tensile strength sutures (FIG. 4, solid line), or eventraditional elastic sutures (FIG. 4, dashed line). Thus, examples of thedisclosed suture are capable of acting like a constant force spring,where force (i.e., strain) is relatively constant over a wide range ofdeflections.

In some embodiments, where a large mass of relatively immobile tissue isto be supported, for example in a breast lift application, it can beadvantageous to provide a suture with a more progressive spring rate. Inthese embodiments, the stress-strain properties of the suture or supportsystem can be optimized to simulate the natural biomechanical propertiesof the tissue. For example, in the case of a system for supporting thebreast, the force/deflection characteristics of the support system canbe designed to simulate that of Cooper's ligaments, or the combinationof Cooper's ligaments and tissue that make up the outer structure of thebreast.

Commonly used suture materials do not normally exhibit the properties ofhigh elongation that are desirable in plastic surgery procedures.Natural materials, such as collagen, do however provide a highlyextensible matrix that is useful in embodiments of the presentdisclosure. Collagen based sutures are often referred to as “gut”sutures. The source of collagen is varied and can include, withoutlimitation, intestinal submucosa, pericardium, and tendon, from animalsincluding humans, cow, pig, horse, donkey, kangaroo, and ostriches, etc.

Where the source of collagen is a native tissue, the tissue can be fixedin order to cross-link the collagen. Common fixatives includeglutaraldehyde. Where greater extensibility is desired, chromic acid canbe used as the fixative. Still other fixatives can be used, and thechoice of fixative is not considered to be limiting to the scope of thepresent disclosure. For example, tissues can be fixed using radiation,dehydration, or heat.

In some embodiments, the suture can comprise a core made from a highlyelastic synthetic polymer. Some suture materials can be made fromformulations that are elastic in compression but have low strength intension, for example hydrogel polymers. In some embodiments, thebiocompatible gelling material is a solution containing water-insolublepolymers, for example non-cross-linked acrylonitrile polymers or theirco-polymers, polyvinyl acetate, a linear or low-branched polymer orcopolymer of 2-hydroxyethyl-acrylate and methyl acrylate,poly-n-vinyliminocarbonile and dimethylsulfoxide or other polar orreadily water miscible solvents, for example as disclosed in U.S. Pat.No. 4,631,188 to Stoy et al., the contents of which are hereinincorporated by reference in their entirety. These exemplary polymerssolidify when placed in contact with living tissue as a result ofabsorption of water from the tissue and gradual release of the solventinto the surrounding tissue.

In obtaining copolymers, use can be made of additional monomers, such asacrylamide (including N-substituted), acryl hydrazide (includingN-substituted), acrylic acid and acrylates, glutarimide and vinylsulfone. Solvents can include glycerol and its mono- or diacetates,methanol, ethanol, propanol and iso-propanol, dimethylformamide,glycols, and other suitable solvents.

In some embodiments, the core 30 can be covered with a braided portion40 as shown in FIG. 5A. The braid can be made from traditional hightensile strength suture materials. Here, the angle of the braid can beselected such that the braided structure can elongate from its freestate. Elongating the braid results in a decrease in the diameter of thelumen of the braid, and in turn results in compression of the core 30,which in turn resists further deformation of he braid. An embodiment ofa suture core with the braid 40 relaxed is shown in FIG. 5B. As indictedabove, in embodiments employing a hydrogel polymer core, the corematerial will be weak in tension, but will effectively resistcompression.

In some embodiments, the core 30 can be separated from the braidedportion 40 by a membrane 60 that prevents the individual braid filamentsfrom cutting into the core material, as shown in FIGS. 6A and B. Againthe angle of the braids, relative to the longitudinal axis of the core(0 in FIG. 6B), can be selected such that the braid can be elongated.

In some embodiments of a highly elastic suture, the suture includes acore 30, a braided portion, 40, all of which is impregnated with anelastomer 70. In some embodiments the elastomeric portion can comprise a“core” of one or more components the device. In some embodiments, anelastomeric material can be used to cover device components. In someembodiments, an elastomeric material can cover other portions of thedevice, providing an “elastomeric cover.” For example, duringmanufacture, the suture can be forced into a foreshortened configurationand then impregnated with an elastomeric coating. The elastomer 70 cansubstantially impregnate the weave of the braid 40 and is effective tobehave mechanically like an additional “core.” The elastomer is alsoeffective to provide resistance to elongation. Neither the compositionof the elastomer, nor methods of coupling or applying it to othercomponents of the suture are limiting. Conveniently, in someembodiments, the elastomer can comprise without limitation, silicone,thermoset polyurethane, glycolide-co-caprolactone, copolymers of lacticacid and sebacic acid, and the like, as well as combinations of morethan one elastomeric material.

Shrinkable Sutures

In some surgical applications, an advantage is provided by embodimentsthat are able to gradually shrink in length over time, or which can bemade to shrink at a later time, in response to an activation provided bya physician.

In some embodiments, a shrinkable suture 80 comprises a core 30surrounded with a filamentous braid, as shown in FIG. 8A. Here the angleof the braid is such that as the core is allowed to expand in diameterit applies a force to the braid which shortens in length as a result, asshown in FIG. 8B. Shortening of the braided portion results in anoverall shortening of the entire suture. The core material can comprisea hydrogel or other suitable swellable material.

In some embodiments, a shrinkable suture comprises a bioabsorbable core,surrounded by a shape memory or other form of bias member. When placedin the patient, the bioabsorbable core 35 is absorbed over time. As thebioabsorbable core is absorbed it will weaken, with the result beingthat the force generated by the bias member, will dominate thebiomechanical property of the suture.

In some embodiments, an example of which is shown in FIG. 9, theshrinkable suture 80 is configured to shrink in response to anactivation energy or signal. In one case, a shrinkable suture comprisesa shrinkable core 35 that heals into the tissue into which the suture isplaced. In some embodiments, the shrinkable core 35 comprises collagen.The shrinkable suture 80 further comprises an energy transfer member 85for delivering energy to the shrinkable core 35. In some embodiments,the energy transfer member 85 comprises a wire that can be heated by RFenergy, or via a directly applied electrical current. Upon heating, thewire transfers energy to the shrinkable core 35, which in turn resultsin heating of the shrinkable core 35. In response to the thermal energy,the shrinkable core 35 in turn shrinks, creating tension in the tissueinto which the shrinkable suture 80 is embedded. In the case of ashrinkable core comprised of an unfixed tissue, a temperature of 42° C.can be effective to result in shrinkage. In some applications it canalso be desirable to cool the tissue immediately after the heatshrinkage step in order to minimize damage to surrounding tissue.

In some embodiments of a shrinkable suture, the suture comprises a firstmaterial 185 having a relaxed length and a deformed length, where thedeformed length is longer that the relaxed length. In some cases thedeformed length is 10-30% greater than the relaxed length. In someembodiments, the suture is extended to its deformed length, and thatconfiguration held by a second material 135 that resists relaxation.Conveniently, the second material 135 can be biodegradable, such thatwhen the suture is placed in the body, the second material is absorbedover time. Once enough of the second material has been absorbed, thefirst material 185 assumes its relaxed length, and the suture shortens.

In some embodiments, the first material can comprise Nitinol or anyother suitably elastic material, as shown in FIG. 9. In some embodimentsthe first material 185 can comprise a shape memory material, that can beactivated after a period of time to assume a memorized length thatresults in shortening of the suture, or an increase in tension impartedby the suture on the surrounding tissue. Activation can be performedafter a period of time sufficient for the second material 135 to beabsorbed by the body.

Tissue Ingrowth

Healing typically occurs in three stages: inflammation, tissueformation, and matrix formation and remodeling. Matrix formation andremodeling can persist for as long as 6-12 months after wounding.Sutures used for temporarily holding tissues together are generallydesigned to minimize inflammation. Sutures designed to support tissue,such as those used in plastic surgery lift procedures, should alsoencourage tissue ingrowth, so that eventually the suture is furthersupported by a column of native collagen-containing scar tissue.

A variety of methods can be used to promote tissue ingrowth. Whensutures made from naturally occurring material are used, this caninclude, methods of fixation of the suture material(s). For example,glutaraldehyde, EDC or epoxy fixatives result in sutures with moretissue ingrowth potential than do other fixatives. Where syntheticsuture materials are used, braiding can be used to enhance tissueingrowth. In some cases, synthetic materials can be manufactured suchthat they are porous. Implants with porosity greater than about 50 to 75gm will generally permit tissue infiltration and vascularization.Porosity can be varied the construction of the suture, for example byproviding a multifilament suture with a loose braid, or with twistedfilaments.

Absorbability

All embodiments described herein can be fashioned from bioabsorbablematerials. Materials can include those from natural sources such as gut,and other like materials, or synthetic materials. A variety of polymerscan be used to produce bioabsorbable sutures including, withoutlimitation, poly(glycolic acid), poly(glactin), poly(para-dioxanone),poly(trimethylenecarbonate), or poly(caprolactone). Differentcombinations of materials can be used to produce sutures that displaydifferent rates of absorption in vivo. In some embodiments, sutures cancomprise both absorbable and non-absorbable materials.

Preventing “Cheese-Wire” Effect

For supporting tissues, especially larger masses of tissue, such as thebreast or buttocks, some embodiments can be designed to prevent what isknown as the “cheese-wire” effect; i.e., cutting through tissue by thesuture or support member due to movement of the suture or supportrelative to the adjacent tissue. Cheese-wiring is particularly evidentwhen using very thin sutures, or ones with abrasive surfaces. In someembodiments, using a suture made from a natural material can beeffective to reduce the cheese-wire effect, due to their relativelylarge cross section and smooth surface, and because they better healinto the surrounding tissue.

In some embodiments, a suture or a support system can comprise a regionwith a wide cross section 90 in at least one direction, as shown inFIGS. 10A and B. Thinner ends 95 can be provided to improve ease ofsecuring the suture in place in the patient. In some embodiments, thesuture can be configured as a thin-walled tube, analogous to anangioplasty balloon.

The suture can be folded down into other configurations. For example, afolded suture 100 can be produced by drawing the unfolded suture, shownin FIG. 11A, through a folding die, as in FIG. 11B. Once the suture isplaced in a desired position, it can be configured to assume a shapethat provides a wider support area effective to support tissue, whilelimiting the extent to which the suture will cut into the tissue. In onemethod, the folded suture 100 shown in FIG. 11B is expanded to form aninflated or expanded suture 110, shown in FIG. 11C, which is thendeflated in order to provide a flattened suture 120, shown in FIG. 11D.

The suture can optionally include supports 130 running either internallyor externally, to provide additional tensile strength, as shown in FIG.12A. In some embodiments, the supports comprises wires running along thelongitudinal axis of the suture. Other supporting elements other thanwires can also be used.

A suture with supports 130 can be reconfigured as described above. Forexample, as with the suture shown in FIG. 11, a portion of a supportedsuture can comprise an inflatable region. As above, the suture 90 can befolded 100, by drawing through a folding die, as in FIG. 12B. The foldedsuture can be expanded 110, as in FIG. 12C, and then flattened 120, asin FIG. 12D.

In some embodiments, the device can be inflated with an inflation media.In some embodiments, the inflation media can be removed and the devicedeflated, or the inflation media can remain, in which case the deviceremains inflated. In some embodiments, the device can be inflated with afluid (i.e., gas or liquid) that later changes viscosity, converts to agel, or solidifies. In some embodiments, the device can be expandedmechanically by use of a dilation tool. The dilation tool, in someembodiments, comprises a wire or plurality of wires that can also beused to form the device into the flattened configuration 120.

In some embodiments, wires 140 are connected to opposite ends, of abraided section 40, as shown in FIG. 13. Tensioning 145 of the wireswill result in shortening and widening of the braided region, resultingin a wider support area.

In some embodiments, an expandable suture can be fashioned from a smalldiameter, expandable tube. In some embodiments, a second suture passesthrough the lumen of the tubular suture, and is attached to a plughaving a significantly larger diameter than the inner diameter of thetubular suture. Once the tubular suture is in place in the patient, theplug is drawn through the tubular suture, resulting in expansion of thetubular suture diameter. In some embodiments, the tubular suturediameter can be expanded by 500%. By optimizing the wall thickness ofthe tubular suture, the suture once expanded, will tend to assume aflattened configuration.

In some embodiments, a suture can be expanded with a heated fluid.Increasing the temperature of the suture can provide several advantages,including, and without limitation, allowing easier expansion of thesuture, accelerating tissue-ingrowth, and inducing shrinkage of collagenin the region surrounding the suture.

In some embodiments, a suture 150 is provided as a flat strip ofmaterial, which can then be rolled up into a smaller diameter for easierinsertion into the patient, as shown in FIGS. 14A and B. Afterinsertion, the suture can be unrolled back to the flattenedconfiguration to provide more effective tissue support. In someembodiments, at least the flat portion of the suture comprises a shapememory material, such that it spontaneously assumes a flattenedconfiguration upon release from a delivery device, for example a sheath,specialized needle, or trocar.

In some embodiments, a suture can comprise a plurality of wires 170coupled to either an anchor point, or a gathering point 175 short of ananchor point, as shown in FIG. 15. Providing a multiplicity of wireseffectively spread out the weight of the tissue being support, therebyreducing the tendency for a single wire to cut into tissue.

In delivering embodiments of a suture as described herein, the suture 10can be provided attached to a needle 180, or inserted inside aprotective delivery sheath 190, as shown in FIG. 16A. Delivery of abarbed suture inside a trocar, sheath, or catheter, for example, allowsefficient delivery of the suture regardless of the orientation of barbs.In some designs, delivery of barbed sutures by needle required that thebarbs be oriented such that the suture can glide into the tissue intowhich it is inserted (i.e., the barbs face away from the direction ofinsertion). These designs also require that the skin be punctured asecond time in order to access the implanted needle, so that it can betrimmed from the suture and removed following suture placement.

In embodiments of the present disclosure where the suture can bedelivered within a trocar or sheath, some techniques permit delivery ofthe suture with only a single skin puncture. This can reduce the risk ofcomplications due to infection, reduce the amount of pain involved in aprocedure, and allow for more rapid recovery of the patient. Inaddition, use of a the delivery sheath can prevent engagement of thetissue by the barbs until the sheath is removed, as so sutures withbidirectionally oriented barbs 200 can be easily delivered.

For example, with current sutures, performing a facelift procedurerequires sutures enter near the hair line and exit through the cheeknear the nasolabial fold. After the procedure, the patient is left withsutures that protrude from the face, which is aesthetically unappealing.In response, the suture ends are trimmed such that they lie just belowthe surface of the skin. In some case, however, the ends can erodethrough and reappear on above the surface of the skin. Trocar or sheathdelivery avoids these problems.

In some embodiments, one of which is shown in FIG. 16C, a deliverysheath 210 for a suture 10 includes a small opening through which aportion of the suture can protrude. A region at or near the tip of thesuture can comprise a barbed end 220. During placement of the suture,the suture can be substantially fully enclosed within the sheath, suchthat the barbs do not grasp tissue while the sheath and suture are beingadvanced, as shown in FIG. 16C. After the suture end is in a desiredlocation, the barbed end 220 of the suture 10 can be advanced out of thesheath 210, allowing the barbs to engage adjacent tissue 225. Onceengaged, the barbs will effectively anchor the end of the suturesubstantially in place, while the sheath is withdrawn, exposing theremainder of the suture, as shown in FIG. 16D. The suture can includeadditional barbs 20 in addition to those located at or near the end, tofurther anchor the suture in place once the delivery sheath has beenremoved.

In some embodiments, a trocar 240 that is open at both ends 240 can beprovided to deliver the suture 10. A barbed suture can be passed throughthe trocar, the barbs oriented so that the suture, once exposed toadjacent tissue, resists movement relative to the trocar. In someembodiments, a length of the barbed suture extends out from the end ofthe trocar, as shown in FIG. 16E. The length of suture extending fromthe suture can be from about 0.5 cm to about 5 cm, although this is notconsidered limiting. Pushing on the trocar results in the exposedportion of the suture doubling back on itself, such that the barbs willengage the adjacent tissue, as shown in FIG. 16E. Once the end of thesuture is set in place, the trocar can be withdrawn, leaving the suturein place. Tensioning can be performed in a similar manner as that usedwith other barbed suture embodiments described herein.

The distal end of the trocar can be cut at an angle or ground such thatthe end of the trocar forms a point, while providing room for bending ofthe suture. In an exemplary embodiment, a trocar has a 0.5 mm OD and a0.3 mm ID, and is about 225 mm long. A suture of slightly less than 0.3mm diameter fits easily within the trocar.

In some embodiments, coaxial arrangement of a support materialsurrounding the suture can be used to improve pushability of the suture,as shown in FIG. 16F. The support member 250 can be coupled to theproximal end of the suture to aid in delivering the suture with apushing force. After delivery, cutting the end of the suture distal ofthe coupling would release the support from the suture, and allowwithdrawal of the support and trocar, leaving the suture in place. Thesupport member can be made from a variety of materials including,without limitation, Nitinol, surgical steel, or polymers such as PEEK,polyimide, polyethylene, polypropylene, or composite material suitablefor use in medical devices such as catheters.

In some embodiments, the delivery system includes a multi-part needle,as shown in FIG. 17A-D. In some embodiments, the needle has twocomponents, a needle 260 having a first radius of curvature, and ahypodermic tube 270 having a second radius of curvature. The firstradius will be greater than the second radius. For example, the firstradius of curvature of the needle can be 5 cm, while the radius ofcurvature of the tube can be 15 cm. The needle and tube are coaxiallyarranged such that the needle is slidably held within the tube.

In using this system, the surgeon can continually alter the path of thesuture by simply regulating how much of the needle 260 is held withinthe hypodermic tube 270. Where less of the needle is within the tube,the radius of curvature will be dominated by the shape of the tube andhave, in this example a radius of 15 cm. Where more of the needle iswithin the tube, the needle will force the tube to take on a shape witha smaller radius, and thus follow a track of smaller radius, for examplea radius of 5 cm. Thus, the surgeon can advance a suture over a more orless curved path, as shown in FIGS. 17C and D.

It will be readily understood that the radii recited above are providedonly as examples, and various combinations of needles and tubes withvarying radii can be used. In addition, the system can include a needleand a plurality of tubes, such that the device could be telescoped inorder to provide even finer control of the suture path through tissue.

Coaxial, multiaxial, steerable designs can also be applied to thetrocars and catheters as described above. In addition, the systems canalso include guide wires that the trocar or catheter passes over. Guidewires can include a needle tip and be steerable, providing an evensmaller radius pathway through tissue.

To aid the physician in placing sutures, the suture can includeidentifiers to mark barbed regions, or the length of the suturecontained within a trocar, for example. In one embodiment, the suture iscolor coded with a particular color indicating a barbed region, while adifferent color can be used to indicate a non-barbed region. In someembodiments, other colors or marking can be used to indicate regionswith distinctive mechanical properties. For example, and without beinglimiting, a third color can be used to indicate a region of increasedelasticity.

During the surgical procedure, visualization can be accomplished bydirect or indirect methods, including ultrasound, MRI, CT, or using anendoscopic tool and camera combination, among other imaging modalities.Sutures, needles, and trocars, can include markers as are known in theart for visualization when using radiographic imaging modalities. Suchmarkers can be made, without limitation, from metals such as gold,platinum, stainless steel, and other suitable metallic alloys or evennon-metallic materials. Such markers can be included during themanufacturing process.

An advantage provided by some suture embodiments, as described herein,is the ability to adjust or re-tension the suture after placement.Adjustment permits the surgeon to maintain a particular tissueconfiguration and appearance over time. In some cases, such as where thesuture does not include barbs, or where the suture does not protrudethrough the skin and is therefore relatively inaccessible, an additionaladjustment mechanism can be included with the suture, in order toprovide a way in which to vary tension of the suture during the courseof the healing process, and even afterward.

In some embodiments, the adjustment mechanism comprises a knot and aratchet mechanism. In some embodiments, the adjustment mechanism cancomprise a tang in a groove, analogous to a zip tie device. Wherepossible, embodiments comprising a knot are designed to be low-profile,such that the adjuster does not produce a bump, or erode through theskin.

In some embodiments, the ends of a single suture, or the ends of twoseparate sutures, can be joined by a linking device, where a first endis a tube 290, and a second end has a substantially round cross-section300, as shown in FIG. 18. The second end is inserted into the tubularsection of the first end. A skived area near the first end allows thesecond end to protrude.

A variety of methods of securing the first and second ends can be used.In some embodiments the ends can be secured by an adhesive that is curedin response to heat, pressure, moisture, or a chemical catalyst. In someembodiments, the tubular section can be made to be shrinkable, oralternatively be made from a shape memory material. In some embodiments,the second ends includes barbs that engage the first end, or a featureon the first end such as a pocket. In some embodiments the barbs can beon the first end, in the lumen of the tubular portion, and engage thesecond end which can be barbed or not. The second end can furthercomprise a textured surface, or multiple regions of varying diameter tobetter engage the first end. In some embodiments, a tubular sectionengages two separate sutures having substantially round cross sections.In some embodiments, the tubular connector section can be deformable,and will adapt to the cross-sectional shapes of the sutures to bejoined. Conveniently, the tubular member 290 can include an anchor 294,for securing the joining device in place in the patient. A suture endcan also include an anchor 292.

A number of embodiments of the present disclosure are compatible for usein performing breast lift procedures. In some embodiments, the supportmember can be composed of Proline, a non-elastic polymer line. Thesupport member can be placed underneath the breast tissue, and securedby means of a knot or a fastener to a body landmark such as a tendon,bone, or the like. As described above, the system can include suspensionmembers that are either elastic or non-elastic. The system can furtherinclude a safety disconnect, permitting the suspension members torelease when under an increased load, in order to prevent damage to thebreast tissue by the support system.

Use in Breast Procedures

In some embodiments, sutures of the present disclosure are used toperform a minimally invasive breast lift, as shown in FIG. 19. In onemethod, suspension members 330 are inserted through the skin andadvanced at a depth of between about 2.5 and 25 mm under the skinsurface. The suture is passed through the Cooper's ligaments and fattytissue. One or more loops of suture material are looped under the breast320, and suture ends are attached to an area in the chest 342, servingas anchor points for the suspension members 330. The sutures aretensioned in order to simulate support provided by natural, healthyCooper's ligaments, as shown in FIGS. 19 and 20, and are effective tolift the breast 320 (compare left and right panels in FIG. 19).

In some embodiments, the attachment to the chest areas comprises a loopof suture material threaded around a portion of the pectoral muscle,fascia, sternum, a rib, or a ligament, or combinations thereof. The loopis inserted through the skin with a small caliber needle, and positionedbelow the top edge of the breast, so that the suture support is notvisible through the skin. A curved needle attached to the suture can beused to insert the suture material. In some embodiments, the needlecomprises two parts that are axially movable relative to each other, andwhich have different curvatures, such that the surgeon can adjust thecurvature of the needle is it is being inserted. In some embodiments,the suture is delivered within a sheath.

In some embodiments, the anchor can comprise a bone screw, attached tobone or cartilage in the sternum or rib cage.

In some embodiments, a suture 330 can run from the anchor point 342,along one side of the breast 320, under the breast, and up the otherside back to the anchor point 342. A number of sutures 330 placed inthis way will be effective to cradle and lift the breast from below. Insome embodiments the sutures 330 could run down either side of thebreast and attach at support points 340 either under or to one side ofthe breast. A number of possible ways of placing and orienting sutureswill be possible in achieving lifting of the breast while maintainingbreast symmetry and aesthetic appearance. These various arrangements andcombinations will be apparent to those of skill in the art.

In some embodiments, the suture lines can be extended transcutaneouslyaround the nipple area to preferentially reposition this portion of thebreast. This corrects the situation where the nipple turns downwards inresponse to age or as a result of breastfeeding. Looping a suture linearound the nipple provides for support of the nipple, without having tosupport the entire weight of the breast. Where a nipple repositioningtechnique is used, the suture can be anchored using the methods asdescribed above.

In some embodiments, lifting of the pectoral muscle is used to adjustthe physical appearance of the breast. A method to modify the muscletissue by shortening it can comprise cutting the muscle and drawing ittogether, or drawing it together using a series of threads similar to acorset. Lacing the tissue together results in lifting of the breasttissue resulting in a more youthful appearance, and a reduction inbreast ptosis.

In some embodiments, shortening of the muscle fibers is accomplished byinternal anchors deployed into the muscle fibers. Drawing the anchorstogether in turn draws the muscle tissue together. The anchors can beconnected by suspension members comprising elastic or inelasticmaterials. Elastic material can be used to allow for normal loadingconditions such as physical movement and activity. Additionally, elasticmaterials can result in further lifting of the breast tissue.

Elastic material examples can include, without limitation, silicone corebraided materials similar to a “shock cord” construction, polypropylenemesh as used in hernia mesh, NiTi alloy wires or braids, coiled typesprings, and similar materials and combinations known in the art. Insome embodiments the materials distribute the entire load throughout thelength of the suspension line limiting longitudinal movement. In someembodiments, the suture lines comprise relatively inelastic materialsincluding, without limitation, polypropylene suture, NiTi wire,stainless steel wire, polypropylene mesh and the like. These materialscan be attached to anchors such as barbs, hooks, flared materials suchas NiTi elements and the like.

This system can be foreshortened during initial implantation or postimplantation with mechanisms such as, and without limitation, screws,loops, cams and rotary pulleys, or any other means effective to shortenthread or wire-like elements. The muscle can be additionally suspendedby hernia mesh material and tied to land marks such as, withoutlimitation, bone, fascia, tendon, and other areas that would bear theloading conditions. In some embodiments an exemplary diameter of asuspension line can range from about 0.005 inches to about 0.090 inches.In some embodiments the diameter of a suspension line would be about0.030 inches.

In some embodiments the material permits tissue ingrowth, and thus moveswith the native tissue, reducing irritation and cutting of the tissue.The material can be coated with a therapeutic agent to enhance tissueingrowth, and in some embodiments the suture material is manufactured toinclude the therapeutic agent. In some embodiments, the therapeuticagent is added just prior to implantation, either by impregnation, bycoating, or by a combination of the two processes.

In some embodiments, coatings or treatments can include an inhibitoryagent to limit or prevent tissue ingrowth such that the material willnot adhere to the surrounding tissue. In some embodiments a suspensionline runs through a cylinder of fluid that allows movement between thesuspension line and the tissue.

In some embodiments the support system comprises suspension members 330are provided that are oriented in a substantially vertical orientation,as shown in FIG. 21, and attach to an anchor point 340 above the breast.The support members 360 are coupled to the suture lines 330. In someembodiments, angles for suspension members other than vertical are usedto customize the shape of the breast or where the procedure is used tocorrect breast asymmetries. As shown in FIG. 22, angled suture lines 380can provide lifting or additional lateral adjustment, in addition towhat can be provided using vertically oriented suspension members. Forexample, by placing the support lines angled either to the right or leftof vertical, the nipple and/or breast may be adjusted medially orlaterally as desired by the surgeon, in addition to verticalrepositioning. In some embodiments, a vertical support line andsecondary tensioning line can be used, and the vertical lines can thusbe pulled laterally, redirecting the force vector supporting the breasttissue. In some embodiments, it can be useful to provide laterallyoriented suspension members alone, such as where lateral repositioningis required, but lifting is not desired or otherwise indicated.

In some embodiments, the support system comprises components withnon-linear elastic constants (e.g., a secondary elastomer to increasethe load bearing at the bottom of the stroke). This allows for normalsupport while standing, and provides additional load bearing capacityduring activities such as walking, running, and jumping. In someembodiments, components that allow for complex loading are designedusing larger cross sectional areas or by providing components fashionedfrom more than one material, where the individual materials havedistinct elongation characteristics. In some embodiments first 400and/or second 410 elastic components can be used to provide more complexmechanical behavior, as shown in FIG. 23. In some embodiments, the firstand/or second elastic components can comprise springs. In someembodiments, the first and second elastic components can have the sameor different elastic constants. In some embodiments, the first and/orsecond elastic components can be positioned anywhere along the length ofa suspension member.

Safety Disconnect

In some embodiments, a safety release 390, shown in FIG. 23, provides amechanism to protect the attachment area or the supported tissue fromdamage caused by support system components when large loads are imposedon the tissue and/or the support system. For example, excessive load canoccur during excessive motion or concurrent with a trauma. The safetyrelease 390 is designed to separate the support member 360 from thesuspension members upon exceeding a defined loading.

In some embodiments, the safety release 390 comprises a regionengineered to fail at a predetermined limit. In some embodiments themechanism comprises a necked section to allow for yielding. In someembodiments, a slip disconnection that decouples, or a joint thatunlatches can be examples of effective safety releases. In some casesthe safety release mechanism can be designed such that it can bereconnected or repaired following release. The loading limit effectiveto result in release of the suspension members from the support membercan range, for example, from about 0.5 kg to about 8 kg, and inparticular from about 1 kg to about 3 kg of force.

In some embodiments, selecting the elastic characteristics of thesupport member to carry partial or complete loading can allow for aleast amount of tissue movement relative to the suspension element. Insome embodiments, the entire length of the support system can assume thestress where the least amount of movement is shared throughout theentire system. Continuous length elastic elements 420 can be used tosupport the loading to lessen the stress concentrations in one area ofthe implant, as shown in FIG. 24. In some embodiments, the system canalso include an adjustment mechanism 350, useful to vary the tensionexerted on the tissue by the support system either at the time ofimplantation, or later once the healing process is complete or nearcomplete. Adjustments could also be made over extended times in order tomaintain the supported tissue in a desired position.

Support Member with Inflation Pleats

In some embodiments, the support member can include additional loadcarrying or shock absorption capability. For example, hydraulic (gas orliquid) elements can provide a resilient cushion in order to compensatefor various loading conditions, such as jogging and other sportingactivities, or to absorb some of the effects of trauma. In someembodiments, shock absorption is provided by a support member comprisinginflation chambers 430. The chambers can be configured to compressduring heavy loading, with compression providing the resiliency toreturn the device to a pre-loading configuration once the activity orother source of loading has ended. Similarly, the system can include acharged system, analogous to an automotive shock absorber, to dampenloading, and where the charge would allow for recoil loading.

The chambers can have a wall thickness in a range, for example, fromabout 5 μm to about 250 μm, depending upon the material, the inflationpressure to be used, and the degree of resiliency desired. There can bea single chamber or multiple chambers. Material choice, chamber wallthickness, and/or inflation pressure can provide customized mechanicalproperties to support members. In some embodiments, the length of thechambers ranges from about 5 cm to about 15 cm, and width ranges from0.5 cm to about 4.0 cm. In some embodiments, the length of the inflationchamber is about 10 cm, and the width is about 3 cm. Precise shapes anddimension can be varied depending on the particular anatomical makeup ofthe patient, or on the kind of support or aesthetic results desired.

In some embodiments, the chamber(s) can be filled with a media thatsolidifies or gels. In some cases, the media remains in a liquid form.Composition of the media can include, without limitation, silicone,saline, epoxy, and any other safe implantable fluids, solids, or gasesthat will be substantially retained within the chamber(s).

In some embodiments, addition of one or more volume elements supportedby suspension elements can be used to augment low volume breast tissueand enhance the final outcome with respect to a patient's fullness. Thevolume element can comprise a prior art augmentation device such as asilicone or saline implant or it can use a dermal filler to soften thelook of the breast. In some embodiments, support members comprisingchambers 430, an example of which is illustrated in FIG. 25, can beadapted to provide volume enhancement. Fillers can include, withoutlimitation, commercially available materials such as Radiance, Juvedermor other suitable filler materials. Additionally, the patient's owncells or other tissue could be used to offset the decrease or need foradditional filling. These cells could be harvested and replaced orharvested and processed by centrifuging or filtering to collect cellssuitable for implantation.

In some embodiments, different connection points for suspension andsupport members can be used to adjust the position of each breastseparately, or to allow shape changes that improve the cosmeticappearance of the breasts, for example to provide symmetry.

Folded Support Member for Easier Insertion

As described above, in some embodiments the support system is foldedprior to delivery. Folding reduces the device profile, such that asmaller incision can be used to provide an entry point when introducinga support suture or system into the body. The smaller incision in turnlimits the size of the scar resulting from the implant procedure. Anumber of manipulations well known in the art including, withoutlimitation, rolling, folding and twisting of the support member, can beused to reduce the device profile prior to delivery.

Post-insertion, the mesh support member can be opened and flattened forfinal placement. In some embodiments, the unfolding process is performedusing specialized instruments, such as a small tool 440 in similar inshape to a “hockey stick” as shown in FIG. 26. Spoon shaped tools arealso effectively used to unfold and place the device in the desiredlocation.

Support System Including Barbed Elements

In some embodiments, the support member 360, the suspension members, orboth, can comprise engagement members, for example, barbs 20, as shownin FIG. 27. Barbs are effective to improve engagement of the adjacenttissue and reduce movement of the support system relative to the tissue.Barbs can be fashioned from materials similar to those used to constructthe support member or suspension members, including, without limitation,stainless steel, Nitinol and any other biocompatible materials.

In some embodiments, the barbs can be from about 0.25 mm to about 2 mmin diameter, and from about 0.25 mm to about 5 mm in length. In someembodiments the barbs are 0.5 mm in diameter, and about 2.5 mm inlength. These are examples of barb dimensions and other dimension ofbarbs can be used without limitation. Barbs can be oriented all in thesame direction or they can be oriented in alternate directions in orderto provide resistance to both proximal and distal movement.

Other Suspension Elements

In some embodiments, the device can comprise a nipple suspension element450 to raise the nipple and/or reposition it with respect to the supportmembers, as shown in FIG. 28. Positioning the nipple using a separateelement allows for separate positioning of the breast relative to thenipple. Including addition suspension or tensioning elements providesthe ability to make vertical and/or horizontal adjustments to thenipple.

Additional Support System Components

In some embodiments, the support system can comprise a webbed, or mesh,support member 360, suspension members 330, and attached needles 260 forinsertion into the patient, as shown in FIGS. 29A and B. In someembodiments, the suspension members and support members can comprise acontiguous structure. In some embodiments, the suspension members andsupport member can comprise separate pieces that are assembled prior touse.

Conveniently, in some embodiments, the support member can be fashionedin the shape of a sling or hammock, an example of which is shown in FIG.29B. As used herein, the term “sling” or “hammock” is intended toinclude, without limitation, a wide variety of shapes and sizes,materials and treatments. A sling (or hammock) can be rectangular, othershapes are also contemplated included oval, circular, elliptical, andtear drop shaped. In some embodiments, the sling can be made of a meshmaterial. The mesh material can comprise one or more woven orinter-linked filaments or fibers that form multiple fiber junctionsthroughout the mesh. The fiber junctions can be formed via weaving,bonding, ultrasonic welding or other junction forming techniques, andcombinations thereof.

In addition to suspension members and a support member, a support systemcan comprise additional components. For example, channels 460 can beused to hide the wire or springs 470, which can be effective toeliminate irritation to the surrounding tissue, as shown in FIG. 30.These channels may be open or closed to either allow or limit contactwith body fluids. In some embodiments, the channel may utilize aperforated channel to allow fluid to flow or move within or around awire or spring. In some embodiments, fluids in channels can serve as alubricant for suspension members within channels.

Where multiple support members are used, separation of the elements canbe provided, as shown in FIG. 31, by separators 480. One or moreseparators 480 between support members 360 can be effective to limitmotion of support members relative to each other. Separators can resistmovement of elements toward or away from each other by geometric columnstrength or tensile stress, respectively. In some embodiments,separators 480 can be measure about 0.25 mm to about 2.5 mm in diameterwith a length of 0.5 mm to about 8 mm. It will be understood that thesedimensions are exemplary only, and other dimensions of separators can besuccessfully used. A variety of materials can be used to makeseparators, including without limitation, plastics, polymers, metals,and these materials can be permanent or absorbable.

Maintaining a defined separation of support members during or postimplantation provides for more even suspension of tissue with loadingdistributed across the effective area encompassed by the supportmember(s). Embodiments of support members can be provided as a meshmaterial with different patterns depending on the loading or stressexpected. Additionally, support members can be fashioned with a presetshape effective to resist collapse when the ends are tensioned as duringloading.

A wire mesh work made from NiTi or stainless steel can allow for aflatter looking implant during loading, whereas a limp thread elementmay provide little support on the sides of the breast when loaded. Thisallows for a rounder shape definition rather than squeezing at each sideof the breast during loading. The wire elements can be pre-shaped andmemory set to allow for normal motion and tissue manipulation.

For example, as shown in FIG. 32A, a wire support 490 included in thesupport member 360 mesh can increase strength and provide means forcoupling the support member to other components of the system. By addingadditional components to the support member, properties of strength orelasticity can be imparted, depending on the choice of materials, forexample, and without being limiting, elastomers, pre-shaped shape memoryelements, springs and the like. These additional elements can be locatedabove or below the mesh or embedded into the mesh for motionencapsulation. FIG. 32B illustrates an embodiment of a wire support 490,separated from the support member 360.

Insertion Method

In some embodiments, there is also provided a method of insertion of thedevice, as shown in FIG. 33A-F. In one embodiment, insertion isperformed by a needle 260 inserted at the base of the breast 320,exiting the other side of the base, and pulling the support member 360through the tissue between the glandular structure and the subcutaneousfat (FIG. 33A). Once the support member 360 is positioned correctly, theneedle 260 can be passed back into the same needle hole and verticallyto the anchoring position (FIG. 33B). As the needle is passed back intothe fascia of the pectoral muscle, the piercing of the fascia iscaptured and the needle is once again pulled out of the transcutaneousneedle hole (FIG. 33C). In the same fashion the other support line canbe passed and the fascia again can be captured and tied to the othersupport member where a knot pusher can be used to slide the knot 345deep beneath the skin where it can be hidden to avoid producing a bumpthat might otherwise show on the surface of the skin (FIG. 33D).Anchoring of the support system can be achieved by looping or otherwisetying the ends of the suspension members to a suitable anatomicalfeature, such as a bone 500, for example (FIGS. 33 E & F).

Some embodiments of a method of insertion of support system include aninitial pathway being introduced under the skin with a guidewire system,and providing a tubular sheath for guidance, along with the ability toexchange wires. A tubular sheath allows the surgeon to maintain accessto a common pathway for device installation and manipulation. Theguidewire can be introduced under the skin through a small trocar orneedle where the softer tubular sheath is exchanged out, and otherelements can be passed through such as thread, suspension elements, andthe like. A larger incision at the lower portion of the breast can beused to introduce a wider support member, for example a sling or hammockas has been described herein. This can include an incision to introducethe wide sling at one or both sides of the breast. Additionally, thesetechniques could be all completed in an open procedure as normally seenin a mastopexy operation.

Additional Exemplary Procedures

Embodiments of sutures as presently disclosed can be used to resuspendloose tissue in the neck region. A suture can be inserted using asimilar technique as that used for a breast lift. The suture can also beconfigured to spread out support over multiple lines, or using slings orother types of configurations as described above, so as to prevent thecheese wiring effect that can occur when using a single thin-linedsutures. Designs applicable for use in breast lift procedures, are thusequally applicable for use in a neck lift procedure.

As shown in FIG. 34, in one method, the suture 510 is inserted under theskin surface and advanced below the surface following a line extendingalong the crease in the skin where the underside of the jaw area meetsthe neck. In some embodiments of a neck lift method, the upper portionof the suture 510 is turned upward and extended posteriorly to the jawbone. The suture can be anchored 340 with a loop of suture material tothe connective tissue located behind the jaw bone and just below theear.

Embodiments of barbed sutures can be used effectively to lift tissue inthe lower thigh area that has sagged down above the knee, as can occurduring aging. Sutures with barbs at either end can be inserted fromabove the skirt line and used to pull the skin from the lower thigh uptowards the tissue in the upper thigh area. The barbs located in thepart of the suture located in the upper thigh region can be anchored tothe dermis, or to tendons, ligaments, bone, or muscle, further below thesurface. The portion of the suture located in the lower thigh area canengage the dermis or fascia, or other tissue, typically at a depth of0.2 to 20 mm below the skin surface. A method similar to that used tolift thigh tissue can be used in the region of the upper arm.

Embodiments comprising barbed sutures can also be used to engage muscle.For example, in some embodiments, sutures can be placed in the abdominalregion, and then tensioned to pull the abdominal muscles back intoposition. In some embodiments, the method can further providing asupport system comprising a series of tabs 530 and sutures 540. In theseembodiments, additional tension canto be applied to the sutures, whileat the same time avoiding pulling the suture through or otherwisetearing the tissue to which they are attached, or through which theyhave been threaded. By weaving a series of line from one tab to theother, the muscles can be further supported, for example as illustratedin FIG. 35. The tabs can be inserted by a small incision, and placedunder the skin. Suture material can be pre-loaded into each tab, andsutures connected to each other by a transcutaneous knot or series ofknots.

As shown in FIG. 36, embodiments comprising barbed sutures can also beused to improve upon prior art methods of performing faceliftprocedures. In the prior art methods, shown in FIG. 36A, sutures 550 areinserted under the skin near the front of the cheek, pass up towards thehairline, where they exit out of the skin. This method leaves exposedsuture ends 560 near the front of the face, which are unsightly.Although these ends can be trimmed such that the ends lie under thesurface of the skin, over time it is possible for these ends to erodethrough the skin and reappear.

In contrast, in some embodiments of the present disclosure, the suture550 is fashioned to have barbs at a first end of the suture. The barbsare effective to engage the tissue and resist movement (or to createtension) once in place. The first end can be delivered into the facialarea through a trocar. In some methods, the insertion point of thetrocar can be above the hairline. Once the first end is in the desiredposition the trocar can be removed wherein the barbs are exposed to, andultimately engage, the surrounding tissue. Tension can be applied tobetter secure the barbed end of the suture within the tissue. The suturecan optionally include markings that inform the surgeon how deeply thesuture has been placed. If placement is unsatisfactory, the same trocar,or a second trocar, can be inserted over the suture to facilitateremoval and/or relocation. The method obviates the need for an insertionpoint near the front of the face, and further avoids having suture endsexposed in the facial region, as occurs with the prior art method.

Once the first end is in place, the second end of the suture can beanchored in the scalp, or other suitable region. The second end can alsoinclude barbs to improve anchoring. To place the second end, the end canconnected to a long needle. The needle can be inserted through the samehole where the trocar was inserted and then advanced up the scalp. Insome embodiments, the distance is from about 3 inches to about 7 inches,although this is not limiting. The suture can be exited through theskin, and satisfactory tension on the suture can be achieved by pullingon the exposed end. In some embodiments, the free end near the hairlinecan be trimmed to below the surface of the skin. In some embodiments itcan be useful to re-tension the sutures after the barbed portions havehealed into the tissue. In these cases, a short portion of the secondend of the suture can be left protruding from the scalp to enable thesurgeon to access it more easily at a later date. The end can be coveredwith a small adhesive bandage, or with a liquid bandage in order toprotect the end.

Use of the above described techniques can be useful if providing liftingfor this buttocks region. In the buttocks, single or multiple supportsystems can be used. The system can designed to provide for additionalload bearing, while preventing cutting or tearing of supported tissueduring movement associated with normal activity. One end of the supportsystem can be attached to the outer hip, while the opposite end can beattached to the upper hip bone. Anchoring in this way provides that thesupport can function effectively under either static or dynamic loadingconditions. In some embodiments, the use of crescent shaped supportstraps can be used to accommodate the majority of the tissue to besupported. Additional branch suspension members can be included to allowfor further lifting and shaping of the tissue. Barbed sutures can beused to improve anchoring within tissues.

Extended Needle

FIGS. 37A-37B depict embodiments of an needle 600 that can be used as aguide, as well as to control tools and implants, over, along, and/orthrough a dissecting path 605. The extended needle will be a full sizeneedle 600 that extends out both exit points on the breast formanipulation by the hand FIG. 37A depicts a bent needle 600, and FIG.37B depicts a bent needle 600 in the breast 610, showing exit points 615in the medial and lateral aspects of the breast. The exit points aredepicted as positioned slightly above the areola, but the exit points615 could also be below, level with, or above the areola, depending onthe desired modification of the soft tissue of the breast.

Double Extended Needle

FIGS. 38A-38D depict embodiments of needles 650 that can be used tocreate a dissecting plane. The purpose of the double extended needle isto create a dissecting plane within the breast. The device consists oftwo extended length needles. In application, the two needles extend outof both exit points 655 of the breast 660 along the same plane. The twoneedles 650 will cross at either exit points, creating an expandablearea between the two needles 650. The area can be manipulated via a‘scissor’ action at either exit point. FIG. 38B depicts relative motionbetween the two needles to create a dissecting plane. In someembodiments, the motion of the two needles 650 is substantially radialwith respect to a longitudinal axis of one or both of the needles.

Double Extended Needle with Sling Guide

FIGS. 39A-39C depict embodiments of dissecting needles 700 that are usedin conjunction with an implantable sling 710. The double extended needlewith sling guide includes two extended needles 700 and a sling 710,which has four loops 715 for attachment, used to guide the sling 710along the dissecting plane. The four loops 715 will be at either cornerof the sling. The two left loops, along the long length of the sling,will be inserted on one needle 700, and the two opposite side loops onthe sling will be inserted onto the second needle 700. Before insertionthere will be two needles with a collapsed sling. Once inserted, theneedles can be manipulated at the exit points in a “scissor” cut tocreate a distinct area plane. Once the needles are expanded, the slingwill also be expanded. The needles can then be removed, leaving theextended sling of proper orientation within the created dissectingplane.

Some embodiments include an internal sheath that is configured to allowthe items (e.g., tools, implants, etc.) to be positioned beforeextending the needles to create the dissecting plane area. The insertionassembly consists of the double extended needle with sling guide havingan external sheath. The sheath may be removed once assembly is installedand before any manipulation of the items within the breast.

“Hockey Stick” Dissector

FIGS. 40A-40D depict embodiments for dissecting tissue or creating adissecting plane. The purpose of the “Hockey Stick” dissector 750 is tocreate a dissecting plane with back and forth motion for slinginsertion. The dissector will be straight with an “L” Shaped end 755.The end will be looped and used to feed the sling through.

As illustrated in FIGS. 40A-40D, the dissector 750 can be inserted intoan exit point 760 in the breast and advanced into the breast to create adissecting plane. In some embodiments, this can be accomplished with asling 765 inserted through the looped end 755 of the dissector, asillustrated in FIG. 40C. With the dissector 750 within the breasttissue, the sling 765 can be advanced to a second exit point 760.

FIGS. 41A-41B depict embodiments of a retractable dissector 800. Thepurpose of the retractable “Hockey Stick” dissector 800 is to create adissecting plane for the sling without interfering with the sling-sutureconnection. The dissector 800 will be retracted into a sheath 805. Oncethe sheath 805 is removed, the end 815 of the dissector 800 will openenough to slide over the sling-suture connection for removal. In someembodiments, the dissector comprises a material having shape-memorymaterial and is oriented, when unrestrained, in the open configurationillustrated in FIG. 41B. FIG. 41A depicts a dissector 800 retracted intoa delivery sheath 805, and FIG. 41B depicts the dissector 800 extendedfrom a distal end 810 of the delivery sheath 805.

Conforming Sheath

FIGS. 42A-42F depict embodiments of a conforming sheath 850 that isconfigured to create a dissecting plane for the sling to be maneuveredwithin. The conforming sheath, when pulled at both ends (FIGS. 42A,42D), maintains a circular shape with a small diameter. Once inserted inthe breast, extending out both exit holes, can be pushed at both ends(FIGS. 42B, 42E) to conform to a varying shape. The varying shape, insome embodiments, will be oval, having a much wider base than height.Expansion of the sheath creates a plane through which a sling can beinserted and advanced. Once the sling is in position within the breast,the conforming sheath may be removed. By pulling at only one end (FIGS.42C, 42F), the sheath will maintain its extended shape over the slingand only contract at exit point 855.

Safety Suture Loop Installer

FIGS. 43A-43C depict embodiments of a safety suture loop installer 900.The purpose of the safety suture loop installer is to automaticallyinstall a safety suture loop 905 around an exit braid to maintaincontrollability once the braid is reinserted. The installer is a doublelayer introducer. The safety suture loop 905 is fed through the firstlayer between the outer layer 910 and inner layer 915. The needle 920with a braid is then fed through the center layer. Once the braid isinstalled, the center layer is removed, leaving the needle 920 withinthe outer layer 910. The introducer is then removed and the safetysuture loop 905 is installed around the braid.

Depth Gauge Introducer

FIGS. 44A-44B depict embodiments of a depth gauge introducer 980. Thepurpose of the depth gauge introducer 980 is to create a method ofknowing the depth of the introducer. The device will be an introducer980 having a disk 985 at specified height around the trunk 990 of theintroducer 980. The introducer 980 will be inserted into the skin andfurther insertion will be stopped at the disk 985. During surgery, theuser can use to depth gauge introducer to maintain the entrance portinto the breast (or other soft) tissue at the specified height, or depthwithin the tissue, Xin.

Sling Guide

FIGS. 45A-45C depict embodiments of an expandable sling guide 1000. Thepurpose of the sling guide 1000 is to guide the sling 1005 over thepre-inserted extended needle 1010. The guide 1000 can have an exitcontrol 1015 used to contract a series of loops 1020 on the guide 1000.The loops 1020 can be contracted for insertion at the exit hole and canextend up once inserted (FIG. 45B). The contracting portion will also beused, once inside the breast, to create a dissecting plane. Once thesling 1005 is in place, the sling guide 1000 can be removed, leaving thespecified form for the sling 1005.

Retracting “Diamond” Dissector

FIGS. 46A-46B depict embodiments of a retracting “diamond” dissector1050. The purpose of the retracting dissector 1050 is to easily create adissecting plane within the breast. The retracting dissector 1050 will,in some embodiments, have a button 1055 at one end 1060, outside of thebreast. The button 1055 can be pressed to extend the retractingdissector 1050 into a narrow and sleek shape (FIG. 46A). Once the button1055 is released, the dissector 1050 is extended out to a flat and wideshape (FIG. 46B) having an increased cross-sectional measurement ordimension. Depression of the button 1055 can be used to create a backand forth “cutting” action.

Retracting ‘Diamond’ Dissector with Sling Mount

FIGS. 47A-47B depict embodiments of a retracting “diamond” dissector1100 with sling mount. The purpose of this device 1100 is to create adissecting plane while installing the sling 1105. The device 1100 willhave a control button 1110 at exit point that will extend a flat andwide portion 1120 to create a dissecting plane. The button 1110 can bedepressed to create a back and forth action to “cut” the plane. Theportion will have a sling 1105 attached to it that will contract andexpand with the “diamond” portion of the device.

In operation, the device can be advanced from the distal end of anelongate body 1115 that is inserted into the tissue of the patient. Asthe button 1110 is depressed, the flat and wide portion 1120 can changebetween a compressed configuration and an expanded configuration. Thischange can permit advancement through the tissue in the compressedconfiguration and expansion of a channel (or dissecting plane) in thetissue by expanding the device 1100. In some embodiments, the device1100 can be retractable into the elongate body 1115 (FIG. 47B). In someembodiments, the device 1100 can have a plurality of flat and wideportions 1120, as depicted in FIG. 47A, that cooperate to secure thesling 1105. In some embodiments, the plurality of portions 1120 can holdor secure the sling 1105 therebetween, for example by pinching the slingbetween the plurality of portions 1120, during operation and/oradvancement through tissue.

Retracting Dissector with Sheath Control

FIGS. 48A-48B depict embodiments of a retracting dissector 1150 withsheath control. The purpose of this device 1150 is to create adissecting plane that can be done via sheath 1155 control. The dissector1150 includes a “diamond” shaped point 1160 that changes from acompressed configuration, having a first cross-sectional dimension, toan expanded configuration, having a second cross-sectional dimensionthat is greater than the first cross-sectional dimension, whenunrestrained.

The sheath 1155 can be introduced into a plane within tissue and byselectively advancing the dissector 1150 relative to the sheath 1155,the dissecting plane can be advanced and expanded. As the dissector 1150is advanced out of the sheath 1155, the dissector 1150 preferablyseparates tissue in an axial and lateral direction, as shown in FIG.48B. After the dissector 1150 is expanded, the sheath 1155 can beadvanced over the dissector 1150 to compress and substantially containthe dissector within the sheath 1155 (for example, within a lumen of thesheath 1155). The user is then able to feed the sheath 1155 back andforth over the dissector 1150 as the dissector 1150 moves through thetissue, expanding and advancing the dissecting plane.

Self-Dissecting Sling

FIGS. 49A-49B depict embodiments of a self-dissecting sling 1200. Thepurpose of the self-dissecting sling 1200 is to have one apparatus whichcan be placed but also has the ability to be maneuvered. The sling 1200will have a rigid implant 1205 woven into the sling at the sling-sutureconnection 1210. As the sling 1200 is advanced through a channel intissue, the rigid implant 1205 can be used to increase a cross-sectionaldimension of the channel by separating tissue.

In some embodiments, the rigid portion 1205 will have a “V” shape. Someembodiments provide that the rigid portion 1205 can be contracted forintroduction into the tissue channel. For example, the point 1215 of therigid portion 1205 can act as a dissecting tool, and the two tail ends1220 of the “V” can be brought together and narrowed for insertion inthe exit points of the tissue. After the rigid portion 1205 isintroduced with in the tissue, it can assume its expanded configurationto increase a cross-sectional dimension of the channel by separatingtissue by allowing the two tail ends 1220 of the “V” to expand outwardaway from each other. In some embodiments, the sling 1200 can be drawnthrough the tissue by pulling, and in some embodiments, the sling 1200can be advanced by pushing the sling through the tissue.

“Railroad Tracks”

FIGS. 50A-50B depict embodiments of a “railroad track” dissecting device1250 that includes a plurality (for example, two) needles 1255, orelongate members, that are used in conjunction with a dissecting tool1260 and a sling 1265. The purpose of the device 1250 is to create adissecting plane and to install the sling 1265 at the same time. Thesling 1265 can be connected or coupled to two needles 1255 that will beinserted into the breast. After the needles are introduced, or inserted,in the tissue, the “Railroad Tracks” operation is created by sliding adissector 1260 along each of the needles 1255. The dissector 1260preferably has a substantially rigid configuration that will separatethe needles 1255 from each other as it is advanced along the needles.

In some embodiments, the dissector 1260 is connected or coupled to theneedles 1255 (for example, by eyelets 1270 that extend around eachneedle 1255). As the dissector 1260 separates the needles 1255, theneedles 1255 expand the channel of tissue to increase a cross-sectionaldimension of the channel In some embodiments, as the needles 1255 areseparated, the needles, which can be coupled to the sling 1265, spreadsthe sling 1265 within the channel to increase the cross-sectionaldimension, or width, of the sling 1265 within the tissue. In someembodiments, the dissector 1260 is expandable at least to across-sectional dimension of a width of the sling 1265, such that thedissector 1260 separates the needles 1255, when advanced along theneedles 1255, by substantially the width of the sling 1265. Followingcreation and/or expansion of the plane within the tissue by the device1250, the dissector 1260 can then be removed.

“Wrist Slap” Needle

FIGS. 51A-51B depict embodiments of a needle 1300 having bistableconfigurations. The wrist slap needle has multi-purpose use. The needle1300 will have a natural bent curvature, as illustrated in FIG. 51B.When a force is applied in the upward direction 1305, the needle 1300will then flatten to a straight needle, shown in FIG. 51A. Pressure, orforce, can then be applied in the opposite, or downward, direction 1310to change to needle 1300 to having a bent curvature. Ideally, this toolcan be used as a curved needle during sling application, orintroduction, and then flattened to a straight needle for use with ananchor (e.g., a fascia anchor).

Detectable Sling-Suture Connectors

FIG. 52 depicts embodiments of a detectable sling-suture connector 1350.The purpose of this concept is to have manageability over the locationof the sling 1355 within the breast. By applying sling-suture connectors1350 that can be detected from outside of the breast, those points canthen be determined externally for position modification of the sling1355. In some embodiments, the points of the connectors 1350 can bepalpable externally. In certain embodiments, the points can beechogenic. In some embodiments, the points emit light, and are visibleto the eye.

Sling Exit Points

FIGS. 53A-53B depict embodiments of sling exit points for procedures asdescribed herein. Having predefined sling exit points will ensure properpositioning of the sling and breast lift and direction. There are apossible of 6 exit holes for the breast; three on the outer breast andthree on the inner breast. The three on either side will lie above,across, or below the nipple. The direction of the needle will be acombination of one point on the outer breast to one point on the innerbreast, varying the three points on either side. FIG. 53B depicts atable of possible connectors between the six points.

One Exit Hole Breast Lift

Depicted herein are several embodiments relating to systems, devices,and methods for performing a breast lift through one incision. While thedisclosure below refers specifically, by way of example, to breastlifts, the disclosure can be applicable to lifts, shifting, or movingany soft tissue. Additionally, the embodiments described below can beused in conjunction with other embodiments described in this disclosure.

The one exit hole breast lift consists of an insertion point located atthe bottom of the breast, approximately halfway from the inframammaryfold to the bottom of the areola. This one exit point allows each of thetwo or more breast needles, or other tools, to be directed up to theanchor point, one up medially and the other laterally. The location ofthe hole is dependent of the required trajectory of lift. For mostvertical lifts, the hole would be located at about the halfway point ofthe breast diameter, however, if the lift required is one which thebreast and nipple should be pulled together toward the sternal notchthen the hole may be located along the line connecting the nipple to thesternal notch or mid-clavicle, or positioned slightly laterally. Withthe assistance of a sling port, the same hole may be used for bothbreast needles. For the procedure including an anchor knot located atthe second or third rib, the medial breast needle is directed first andcomes out at the medial anchor point. The anchor needle is then insertedto grab a bite of fascia. The lateral breast needle may then be insertedin the exit hole using a sling port, exiting out the lateral anchorhole. The sling may then be pulled inside the breast, and adjustedappropriately from the two sutures exiting the lateral anchor hole.

The one exit hole breast lift may also be used in conjunction with adistal anchor, which may be deployed from the one exit hole. Once theanchors are secure at either side of the top of the breast, the slingmay be inserted and lifted in order to lift the breast. The suture wouldthen be secured leaving a single closure point at the bottom of thebreast.

In some embodiments, the length of the device used in connection withthe One Exit Hole Breast Lift embodiments is long enough tosimultaneously insert both anchors and still have maneuverable access tothe sling. This length may vary dependent on the site of application andthe tissue being lifted. In addition, a diameter of the access portshould be wide enough, in some embodiments, to encompass two springs atthe same time and also the sling doubled over with two suture stands. Insome embodiments, the diameter of the port accommodates the larger ofthe two.

Variable Length Port

FIGS. 54A-54C depict embodiments of a variable length port 1400. Thevariable length port is designed to change length in order to betterassist with implantation of the device, primarily to accommodatedifferent breast sizes. There is a round disk 1405 that will sit againstthe skin. Also, there is a fixed length sheath 1410 with a handle 1415that the needle can slide into. The port 1400 contains a component 1420similar to a tuohy borst adapter, in which there is a screw lock 1425allowing the sheath 1410 to move up and down then lock into the desireddepth.

Some embodiments provide that the material of the port would be made ofan implantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Thesheath 1410 preferably includes an internal lumen 1430 that has adiameter preferably large enough, in some embodiments, to allow foranchor delivery system and sling component. This diameter may bedependent on the implant location and specification, but it shouldrange, in most embodiments, from about 5 French to about 24 French. Thelength of the device may also be dependent on the implant location, butit should be limited, in most embodiments, to range from about 0.25inches to about 4 inches. In some embodiments, the length may be lessthan about 0.25 inches or greater than about 4 inches. The diameter ofthe sheath 1410, in some embodiments, will be less than about 2 incheson its largest dimension, dependent on the shape of the disk 1405,whether circular or oval, but wide enough to place the sheath 1410, forexample, in the center.

Suture Clamp

FIGS. 55A-55C depict embodiments of a suture clamp 1450. The sutureclamp 1450 is preferably a non-resorbable, two component anchoringsystem with small holes 1455 for tissue ingrowth. The top component 1460contains the anchoring device which will secure into the fascia oradipose. The device top component 1460 will have a line of suturefeeding through a bottom opening 1465 coming out of, for example, twoholes 1470 on either side. The two suture pieces will meet together at abottom portion 1473 of the top component 1460 and feed into the center1475 of the bottom component 1480 of the device 1450 which has a hole1485 down the center 1475. A sheath with a diameter of the bottomportion 1473 of the top component 1460 may be used to drive the topcomponent 1460 of the device 1450. Once in desired location, the suturemay be pulled on to allow for the locking grooves 1490 of the device tosecure into the tissue. Using a smaller diameter tube, the bottomcomponent 1480 of the device may be pushed up into the bottom portion1473 of the already installed anchor. The bottom component 1480preferably includes grooves 1495 that secure the bottom component 1480within the top component 1460 and clamp down of the suture. Afterconnection of the top component 1460 and bottom component 1480 of theAnchor clamp 1450, the sheaths may be removed.

The material of the clamp 1450 would be made, in some embodiments, of animplantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Theoverall length of the device, is some embodiments, will be between about0.125 inches and about 2 inches dependent on the location ofimplantation. In some embodiments, the length may be less than about0.125 inches or more than about 2 inches. In some embodiments, thedevice will be less than or equal to about 0.75 inches in diameter. Thebottom portion 1473 will preferably be wide enough to accommodate thebottom component 1480 of the clamp 1450 and two layers of suturematerial. This range will be, for example, between about 0.1875 inchesand about 0.75 inches.

Hooked Slide

FIGS. 56A-56B depict embodiments of a hooked slide 1500. The hookedslide 1500 is a non-resorbable device with small holes 1505 for tissueingrowth connected to the suture used as an anchoring tool. The slide1500 would preferably be covered by a sheath and fed up to anchor pointin fascia by a hook. Once at the desired location, the sheath and hookcan be removed, leaving the hooked slide 1500 in place. A lower hole1510 is provided for a suture connection. The hooked slide 1500 containsa pointed top portion 1515 to facilitate advancing the slide 1500through the tissue. Downward directing hooks 1520 are on either slide,therefore, allowing ease of insertion. Once at correct location, thedownward hooks 1520 will increase stabilization of the slide 1500 withinthe tissue. In addition, some embodiments provide that there are upwardfacing hooks 1525 to secure the device 1500, allowing the entire deviceto be restrained from both directions.

The material of the hooked slide 1500 would preferably be of animplantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Theoverall length of the hooked slide 1500 will preferably be between about0.125 inches and about 2 inches with a thickness between about 1/32inches and about 0.1875 inches. In some embodiments, the thickness canbe less than about 1/32 inches or greater than about 0.1875 inches. Insome embodiments, the device will be between about 0.0625 inches andabout 0.75 inches wide.

Multiple Dart Suture

FIG. 57 depicts embodiments of a multiple dart suture 1550. The multipledart suture 1550 is one that has multiple barbed ends 1555 connected,for example via a suture 1558, at each side of the sling 1560. Thesewould be inserted up through the sling exit ports. Using a sheath eachindividual suture will be fed up to the anchor point and released. Thesheath may be moved for each portion to allow for a range of securingsites.

The anchor material and size can be dependent of anchor that isattached. The overall length of the dart sutures 1550 is preferablyenough to allow for individual insertion of each device component whilehaving access to the other components out of the exit hole.

Anchor Clasp

FIGS. 58A-58D depict embodiments of an anchor clasp 1600. This devicewould be used as a method of securing two sutures at the anchoring site.The device 1600 preferably allows reversible securing of the sutures,allowing for later adjustments, if needed. One suture 1605 would have aperpendicular rod 1608 (polymer based). The second 1610 would have aring 1609 attached to the end 1615 of the suture 1610. Once the twocomponents are to be secured together, the rod 1608 would besubstantially aligned with an axis passing through a center 1620 of thering 1609 and inserted through the ring center 1620. Once through thering 1609, the rod 1608 would be repositioned to be substantiallyperpendicular to the axis of the ring, ensuring, when properly sized,the inability to release through the ring 1620.

The material of the suture could be made of an implantable graderesorbable or non-resorbable polymer material, including but not limitedto, Polypropylene, Polyester, Nylon, PEEK, Polyurethane, andPolycarbonate. An additional component of the perpendicular rod 1608 andring 1609 may be made of an implantable grade resorbable ornon-resorbable polymer and/or metal material, including but not limitedto, Polypropylene, Polyester, Nylon, PEEK, Polyurethane, Polycarbonate,Titanium, and Stainless Steel.

The length of the rod 1608 would be, in some embodiments, larger thanthe internal dimension (ID) of the ring 1609 by about 1/32 inch up toabout 0.0625 inch over the outer dimension (OD) of the ring 1609dependent of the application and location of implantation. The ring 1609may have an ID ranging from about 0.0625 inch to about 0.5 inch and anOD from about 1/32 inch to about 0.0625 inch. In some embodiments, theID can be less than about 0.0625 inch or greater than about 0.5 inch,and in some embodiments, the ring OD can be less than about 1/32 inch orgreater than about 0.0625 inch. The ring 1609 is preferably large enoughto pass the suture 1605 and the rod 1608 simultaneously.

Zip Tie Sling Closure

FIGS. 59A-59B and 60A-60C depict embodiments of a zip tie slingclosures. The purpose of the non-resorbable zip tie closure is to assistin the securing of the sling rather than using a knot with small holesthroughout for tissue ingrowth. FIGS. 59A-59B illustrates a firstversion of a closure 1650 that is preferably optimally used forbraid-in-braid securing, where there is only one strand of suture tolock. Version one 1650 of the closure is preferably a substantiallycylindrical member having a lumen 1655 extending between ends 1660, 1665of the closure. The interior wall 1668 of the lumen preferably includesa plurality of inwardly projecting members 1670 for securing and/orengaging a suture that is extended through the lumen. The second versionof the closure 1675, FIGS. 60A-60C, is preferably a small button-likedevice that has two holes 1680 for either suture on the sling within thedevice suture would only be able to enter one way. Once inside, thesuture would not release but only be able to pull through the directionit entered because of inwardly projecting members 1685 around each holethat engage the suture extending through the hole. This feature wouldalso allow for future adjustment lifts. In some embodiments, theclosures can be combined, where version one 1650 sits on top of versiontwo 1675 as a single piece, to provide addition securing.

The material of the closure is preferably made of an implantable graderesorbable or non-resorbable polymer and/or metal material, includingbut not limited to, Polypropylene, Polyester, Nylon, PEEK, Polyurethane,Polycarbonate, Titanium, and Stainless Steel. For the first version1650, the length of the device 1650 will preferably be within about0.125 inch to about 0.375 inch. The ID of the tube or cylinder, withoutthe inner teeth or inwardly projecting members 1670, can be that ofdouble the diameter (or cross-sectional dimension) of the suture undercompression. The teeth or members 1670 can be small enough to allow twostrands of suture to pass through but large enough to induce significantfriction if pulled in the opposite side of entry.

For the second version 1675, the diameter of each suture hole 1680 ispreferably equal to or less than the suture diameter (or cross-sectionaldimension) not under compression, so as to allow the suture to passthrough easily but allow the teeth or members 1685 to grab. A stationaryangle 1690 of the teeth 1685 is less than about 90° but flexible enoughto expand to about 90° to allow for suture passage.

Friction Fit Anchor

FIGS. 61A-61B depict embodiments of a friction fit anchor 1700. Thenon-resorbable anchor 1700 contains three holes 1705 at a bottom 1710 ofanchor 1700 and with small holes 1715 throughout for tissue ingrowth.The suture is weaved between these three holes 1705 loosely, allowingaccess for three loops at the exit point. The last suture loop 1720leads directly to the sling. The anchor 1700 is driven into place andonce at the optimal location, suture tightening begins. In order totighten the suture, each loop is pulled until all obtain a friction fitwithin the holes 1705. This will allow the suture to maintain in placewithout movement.

The material of the anchor 1700 is preferably made of an implantablegrade resorbable or non-resorbable polymer and/or metal material,including but not limited to, Polypropylene, Polyester, Nylon, PEEK,Polyurethane, Polycarbonate, Titanium, and Stainless Steel. The overalllength of the anchor 1700 is preferably between about 0.125″ and about2″ with a thickness between about 1/32″ and about 0.1875″. The device ispreferably between about 0.0625″ and about 0.75″ wide. The diameter ofthe suture holes 1705 can approximate the diameter of the suture used.

Anchor Spring

FIG. 62 depicts embodiments of an anchor spring 1750. The non-resorbableanchor spring 1750 is an anchor 1755 with a line of suture 1760 comingfrom the end 1765 of the anchor 1755. The suture will preferably be aspecified length and preferably contains a spring 1770. At the oppositeend of the anchor 1755 and spring 1770, there will be a loop 1775 toallow for another line of suture to feed through. The anchor 1750 willbe deployed independent of the sling, allowing for multiple anchors tobe used and more variations in lift.

In some embodiments, the anchor spring 1750 without suture would be onewith the silicone spring directly overmolded onto the anchor 1755. Thiswould eliminate the need to connect the suture to the anchor 1755, feedthe spring 1770 inside, and then loop at the end 1765.

In some embodiments, the material of the anchor spring 1750 may be madeof an implantable grade resorbable or non-resorbable polymer and/ormetal material, including but not limited to, Polypropylene, Polyester,Nylon, PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel.The overall length of the anchor will preferably be between about 0.125″and about 2″ with a thickness, in some embodiments, of between about1/32″ and about 0.1875″. The device will preferably be between about0.0625″ and about 0.75″ wide. The diameter of the suture holeapproximates, in some embodiments, the diameter of the suture used.

The length of the suture extension that contains the spring 1770 willpreferably be between about 0.25″ and about 6″ depending on the locationof implantation. The loop and the bottom may be created from overlappingthe suture within itself or by applying a separate component that willbe made of the same previously list materials. The ring or loop may havean ID of about 0.015″ up to about 0.25″ and a diameter from about 1/32″to about 0.0625″. The spring will preferably be made of an implantablegrade flexible polymer including, but not limited to, silicone that canbe shorter than the overall length of the suture attachment portion but,in some embodiments, greater than about 0.0625″.

Anchor Spring Device

FIGS. 63A-63C depict embodiments of an anchor spring device. The anchorspring device consists of two or even four anchor springs 1750. Each ofthe springs 1750 has the suture 1780 looped through hole 1775 at the endof the anchor spring 1750. The anchor 1755 is, in some embodiments,deployed up one side of the breast through the bottom anchor hole 1783,such that the two suture ends are protruding, one of the ends being asuture connected to one end of the sling 1785. A second anchor 1755 isthen fed up to the opposing side of the breast and secured into place.For this anchor, there are also two strings protruding, one of which isthe opposite of end of the sling. Now both anchors will be in place andthere should be a sling and two suture ends coming out of the exit hole1783. By pulling the two suture ends, the sling will retract into thebreast through the exit hole 1783 (FIG. 63B). The breast will lift andonce at optimal location, the suture ends may be tied together (FIG.63C) to secure the sling 1785 in place, as shown in FIGS. 63B-63C.

FIG. 63D depicts embodiments of a sling weave anchor spring device 1800.Similar to the sling loop anchor spring device, depicted in FIGS.63A-63C, the two suture ends would be oriented to the exit hole at thebottom of the breast. However, with the sling weave 1800, the two sutureends would be weaved within the sling 1805 to its center and then downto the exit hole. This would allow a knot to be tied at the center ofthe sling. Two main advantages include there being no cheese wiring ofthe suture and the inability for the sling to rotate. Once the anchorsare deployed and at the desired location, the sling may then be pushedup into the breast, by pulling on the suture ends. Once the lift isobtained, a knot may be tied to secure the device.

The material of the anchor 1750 of the device 1800 may include animplantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Theoverall length of the anchor will be between about 0.125″ and about 2″with a thickness between about 1/32″ and about 0.1875″. The device willbe between about 0.0625″ and about 0.75″ wide. The diameter of thesuture hole can approximate the diameter of the suture used. The springwill preferably be made of an implantable grade flexible polymerincluding but not limited to silicone. The length of the springextension will be between about 0.25″ and about 6″.

The length of the device 1800 is preferably long enough tosimultaneously insert both anchors 1750 and still have maneuverableaccess to the sling 1805. This length could vary dependent on the siteof application. In addition, the diameter (or cross-sectionalmeasurement) of the access port (that can be used in connection withthis and other embodiments) should, in some embodiments, be wide enoughto encompass two springs 1770 at the same time and also the sling 1805doubled over with two suture stands. The diameter of the port couldaccommodate the larger of the two. The spring may be implantablenon-resorbable grade flexible polymer including but not limited tosilicone.

Double Anchor Spring

FIG. 64 depicts embodiments of a double anchor spring 1850. Thenon-resorbable double anchor spring 1850 is a spring 1770 with twoanchors 1750 on opposite ends facing in opposing directions. Each anchor1750 has a hole that is connected to a suture 1760, so as to allow forcontrollability of the anchor 1750. Once one anchor 1750 is in place,the second anchor 1750 may be placed to allow tissue to be drawntogether. This can be used for supraareolar lift, as well as for otherlifts.

In some embodiments, the anchor material and dimensions are dependent onthe anchor used. The length of the connecting suture, depending on thelocation of implantation, may be between about 0.025″ and about 6″ long.The suture material may be resorbable or non-resorbable monofilament ormultifilament polymer material. The spring may be implantablenon-resorbable grade flexible polymer including but not limited tosilicone.

Barbed Anchor Release Device

FIGS. 65A-65E depict embodiments of a barbed anchor release device 1900.Starting from a side breast exit point 1903, a needle 1905, or elongatemember, is inserted up to an anchor point in the tissue, withoutpuncturing skin at the anchor point. Once at the correct location, asheath tube 1910 is slid over the needle 1905 up to the anchor point.The needle 1905 is removed, and, a hooked rod 1915 is used to advance abarbed plate 1920, connected or coupled to a suture 1925, through thesheath 1910. Once the barbed plate 1920 is at a desired anchor point,the sheath 1910 is withdrawn, and the hooked rod 1915 releases thebarbed plate 1920, leaving suture 1925 with barbed plate 1920 at theanchor point. The same process can be repeated on the opposite side ofthe breast or tissue. In some embodiments, multiple device 1900 can beinserted through each exit point 1903. Following advancement of thebarbed plate 1920 to the desired anchor point, a sling can be insertedinto the tissue, and a knot can be tied with the suture 1925 on eachside of the sling connecting to anchoring suture 1925. In FIG. 65A, aneedle 1905 is inserted at sling exit hole 1903. A dilator with a sheath1910 is inserted over the needle, as shown in FIG. 65B. In FIG. 65C, theneedle 1905 and dilator are then removed, leaving the sheath 1910 andthe anchor. A hooked rod 1915 slides through the sheath 1910, advancingthe barbed plate 1920, attached to suture 1925, as shown in FIG. 65D. InFIG. 65E, the sheath 1910 is removed, and the barbed plate 1920 is leftin place.

The delivery system is preferably wide enough to encompass the anchor,and in some embodiments, is between about 0.0625″ and about 0.75″. Thelength of the delivery system is preferably long enough to obtaindesired delivery location, and in some embodiments, is equal to orgreater than about 0.25″

Key Hole Anchor

FIGS. 66A-66B depict embodiments of a key hole anchor 1950. Thenon-resorbable key-hole anchor 1950 is one with a key-hole shaped hole1955 (with a key-shaped slot) at the bottom 1960 with small holes 1965throughout for tissue ingrowth. Once the anchor 1950 has been placedproperly within the tissue, the suture may be pulled through the largerportion 1970 of the hole 1955, and once sufficient lift is obtained bypulling on the suture, the suture may be pulled into the smaller portion1975 of the key-hole 1955, locking it into place.

The material of the anchor 1950 is preferably made of an implantablegrade resorbable or non-resorbable polymer and/or metal material,including but not limited to, Polypropylene, Polyester, Nylon, PEEK,Polyurethane, Polycarbonate, Titanium, and Stainless Steel. The overalllength of the anchor 1950 is preferably between about 0.125″ and about2″ with a thickness of between about 1/32″ and about 0.1875″. The devicewill preferably be between about 0.0625″ and about 0.75″ wide. Thelarger portion 1970 of the hole 1955 will be, in some embodiments, equalto the diameter of the suture used. The smaller portion 1975 of the holewill be the diameter of the suture at maximum compression.

“V” Anchor

FIGS. 67A-67B depict embodiments of a “V”-shaped anchor 2000. Thenon-resorbable anchor 2000 is shaped like a “V” with small holesthroughout for tissue ingrowth. The device will be deployed and the “V”shape will allow more area of tissue to be grabbed. Each leg 2005 of the“V” includes smaller barbs 2010 attached allowing for further securing.Each leg 2005 of the “V” will be able to be rotated inward, into acompressed configuration, in order to deliver to the anchoring site. Theanchor 2000 preferably includes a bottom portion 2015 that includes oneor more holes 2020 for securing to a suture.

The material of the anchor 2000 is preferably made of an implantablegrade resorbable or non-resorbable polymer and/or metal material,including but not limited to, Polypropylene, Polyester, Nylon, PEEK,Polyurethane, Polycarbonate, Titanium, and Stainless Steel. The overalllength of the anchor 2000 is preferably between about 0.125″ and about2″ with a thickness between about 1/32″ and about 0.1875″. The device2000 will be between about 0.0625″ and about 0.75″ wide. The hole willbe equal to the diameter of the suture used. An angle 2025 of separationbetween the two legs 2005 can be between about 10° and about 160°, andin some embodiments, the angle between the two legs can be between about10° and about 45°.

Tongue Depressor Anchor

FIGS. 68A-68B depict embodiments of a tongue depressor anchor 2050. Thisnon-resorbable anchor 2050 is one that is shaped like a tonguedepressor, but is bent slightly with small holes throughout for tissueingrowth. Each side preferably contains small barbs 2055. The devicewill preferably be deployed to a desired anchor location within thetissue, and once at the anchor location, the device may be moved backand forth slightly in order to secure into the tissue. This device 2050may be used for supraareolar lift, as well as for other lifts.

The material of the port is preferably made of an implantable graderesorbable or non-resorbable polymer and/or metal material, includingbut not limited to, Polypropylene, Polyester, Nylon, PEEK, Polyurethane,Polycarbonate, Titanium, and Stainless Steel. The overall length of theanchor will preferably be between about 0.125″ and about 4″ with athickness between about 1/32″ and about 0.1875″. The device 2050 willpreferably be between about 0.0625″ and about 0.75″ wide. The angle ofbend in the device 2050 is preferably less than about 180°. The platebarbs 2055 will be bent, in some embodiments, in an directionsubstantially different (or opposite in some embodiments) than thebending of the device 2050.

Wall Anchor

FIGS. 69A-69F depict embodiments of a wall anchor 2100 used inconnection with the systems and methods described herein. Thisnon-resorbable anchor 2100 is diamond shaped when relaxed orunrestrained (FIGS. 69A-69B), and has a pointed head 2105 for driving oradvancing the anchor 2100 through tissue. At a bottom 2110 of the anchor2100, there is preferably a hole 2115 for attaching a suture. The sutureis then fed up to a hole 2120 at the top head 2105 and then back downthrough the bottom hole 2115. When directing the device into place, itstraightens out to be long and thin (FIGS. 69C-69D). Once at a desiredlocation, the suture coming from the bottom 2110 of the anchor 2100 canbe pulled, pulling the top head 2105 and bottom 2110 of the device 2100together, changing the shape to increase a cross-sectional dimension ofthe anchor 2100. The device 2100 will change from the long and thinshape to the diamond shape, and further pulling will allow the device2100 to change from a vertical-oriented shape to a horizontal orientedshape, further engaging tissue substantially perpendicular to directionthat the suture is pulled (FIGS. 69E-69F).

The material of the anchor 2100 is preferably made of an implantablegrade resorbable or non-resorbable polymer and/or metal material,including but not limited to, Polypropylene, Polyester, Nylon, PEEK,Polyurethane, Polycarbonate, Titanium, and Stainless Steel. The device2100 will preferably be between about 0.0625″ and about 0.75″ wide andlong at deployment. An angle 2125 between two legs 2130 extending towardthe bottom 2110 from the top head 2105 will preferably be less thanabout 90° in relation to each other at deployment. The thickness of thedevice 2100 will preferably be between about 1/32″ and about 0.1875″.

Suture In-Weave Anchor

FIG. 70 depicts embodiments of a suture in-weave anchor 2150. Thisnon-resorbable anchor 2150 is one with a suture hole 2155 at the bottom.Passing through the suture hole 2155 is preferably a suture loop 2158 ofbraid that is about 0.25″. One suture tail 2160 is attached to thesling, and the other suture tail 2165 is used for securing. The anchor2150 may be directed into a desired location, and once at the locations,the securing suture 2165 end is pulled until desired lift is obtained.The suture may then be secured.

The material of the anchor 2150 is preferably made of an implantablegrade resorbable or non-resorbable polymer and/or metal material,including but not limited to, Polypropylene, Polyester, Nylon, PEEK,Polyurethane, Polycarbonate, Titanium, and Stainless Steel. The overalllength of the anchor will preferably be between about 0.125″ and about2″ with a thickness between about 1/32″ and about 0.1875″. The device2150 will be between about 0.0625″ and about 0.75″ wide. The diameter ofthe suture hole approximates, in some embodiments, the diameter of thesuture used. The length of the suture extension will preferably bebetween about 0.25″ and about 6″, depending on the location ofimplantation and sufficient to loop within itself in a portion greateror equal to the diameter of the suture itself. The suture material maybe resorbable or non-resorbable multifilament polymer material.

Hybrid Anchor

FIG. 71 depicts embodiments of a hybrid anchor 2200. The non-resorbablehybrid anchor 2200 is a plate 2205 with barbs, (for example, for adiposeand fascia securing) with small holes throughout the anchor 2200 fortissue ingrowth. In some embodiments, adipose barbs 2215 are directedoutwardly in a plane that is substantially parallel to the plate 2205,and in certain embodiments, fascia barbs 2220 extend in a plane that istransverse to the plane of the plate. Some embodiments include bothbarbs 2220, 2215, allowing for securing in both tissues.

The material of the anchor 2200 is preferably made of an implantablegrade resorbable or non-resorbable polymer and/or metal material,including but not limited to, Polypropylene, Polyester, Nylon, PEEK,Polyurethane, Polycarbonate, Titanium, and Stainless Steel. The overalllength of the anchor 2200 will, in some embodiments, be between about0.125″ and about 2″ with a thickness between about 1/32″ and about0.1875″. The device will preferably be between about 0.0625″ and about0.75″ wide.

Trap Anchor

FIGS. 72A-72B depict embodiments of a trap anchor 2250. Thenon-resorbable trap anchor 2250 is one with two plates, a first plate2255 on top of a second plate 2260 in a substantially parallelorientation, with small holes throughout for tissue ingrowth. Each plate2255, 2260 with have a pointed head 2265 for separating tissue while theplate is being advanced through tissue, and each plate is attached at abase 2370, that has a hole 2375 for securing to a suture. As theparallel plates are driven into the tissue, the tissue becomes trappedwithin the two plates by small divots, which allow the tissue to enterbut not exit.

The material of the anchor 2250 is preferably made of an implantablegrade resorbable or non-resorbable polymer and/or metal material,including but not limited to, Polypropylene, Polyester, Nylon, PEEK,Polyurethane, Polycarbonate, Titanium, and Stainless Steel. The overalllength of the anchor will preferably be between about 0.125″ and about2″ with a thickness between about 1/32″ and about 0.1875″. The devicewill be between about 0.0625″ and about 0.75″ wide. The jaw width ispreferably between about 0.15″ and about 0.5″ depending on the locationof insertion.

Bent Barbed Anchor

FIGS. 73A-73B depict embodiments of a bent barbed anchor 2300. Thenon-resorbable anchor is derived from a plate 2305, which has a seriesof barbs 2310 cut out either side with small holes throughout for tissueingrowth. Each barb 2310 is curled outward in some embodiments. Theanchor barbs 2310 may be pushed back toward the plate 2305 while theanchor 2300 is being advanced through tissue to a desired location. Onceat the desired location, the barbs 2310 are released allowing them tosecure into the tissue. In some embodiments, this design may beadvantageous for adipose tissue securing. Also, an alternative versionwould be every other prong bent down, out of plane with the plate 2305,as shown in FIG. 73B, in order to obtain resistance in both the fat andfascia planes. In some embodiments, the anchor 2300 includes one or moreholes 2315 at one end for securing to one or more sutures. In someembodiments, the plate 2305 includes a pointed head 2320 for separatingtissue when the anchor 2300 is advanced through tissue.

The material of the anchor 2300 is preferably made of an implantablegrade resorbable or non-resorbable polymer and/or metal material,including but not limited to, Polypropylene, Polyester, Nylon, PEEK,Polyurethane, Polycarbonate, Titanium, and Stainless Steel. The overalllength of the anchor 2300 will be between about 0.125″ and about 2″ witha thickness of between about 1/32″ and about 0.1875″. The device willpreferably be between about 0.0625″ and about 0.75″ wide. The diameterof the suture hole 2315 approximates the diameter of the suture used.

Barbed Plate

FIGS. 74A-74B and 75A-75B depict embodiments of a barbed plate anchor2350. The non-resorbable barbed plate anchor 2350 consists of a plate2355 with barbs 2360 stamped out of it with small holes throughout fortissue ingrowth. The barbs 2360 are then bent out of plane with theplate 2355 in order to grab fascia once installed in the tissue. Thisbending motion also allows the barbs 2360 to be substantially flatduring delivery of the anchor. Embodiments depicted in FIGS. 74A-74Bcontain one or more holes 2365 at the bottom to create a friction fitwith looped suture. Embodiments depicted in FIGS. 75A-75B containreverse directing barbs 2370 in order to prevent movement upward. Oncethe anchor 2350 is at the desired location, it may be shifted up anddown slightly to properly secure the fascia in both directions.

The material of the anchor is preferably made of an implantable graderesorbable or non-resorbable polymer and/or metal material, includingbut not limited to, Polypropylene, Polyester, Nylon, PEEK, Polyurethane,Polycarbonate, Titanium, and Stainless Steel. The overall length of theanchor will preferably be between about 0.125″ and about 2″ with athickness between about 1/32″ and about 0.1875″. The device willpreferably be between about 0.0625″ and about 0.75″ wide. The diameterof the suture hole approximates, in some embodiments, the diameter ofthe suture used.

Staple Anchor

FIGS. 76A-76B and 77A-77B depict embodiments of a staple anchor 2400.The non-resorbable anchor 2400 is derived from a partial (e.g., half)tube 2405 with a series of teeth 2410 cut out on the sides allowing forsecuring into the fascia. Due to the curvature of the partial tube 2405,the direction of the teeth 2410 will facilitate penetration into thefascia. The back end of the anchor will preferably contain a hole 2415for suture securing and device deployment. FIGS. 76A-76B contain twoholes at back end to allow the suture to loop secure anchor and feedinto the center of the device. FIGS. 77A-77B show a series of holes 2420to optimize ingrowth. In some embodiments, there is a divot createdalong the top of the anchor 2400 for the suture to lay flush on top.This can aid in condensing the delivery sheath diameter. In addition,the teeth 2410 may be bent outward in order to grab the fascia moreeasily. For some of these embodiments, every other tooth 2410 would bebent out slightly and twisted out to create a paddle effect against thetissue.

The material of the anchor is preferably made of an implantable graderesorbable or non-resorbable polymer and/or metal material, includingbut not limited to, Polypropylene, Polyester, Nylon, PEEK, Polyurethane,Polycarbonate, Titanium, and Stainless Steel. The overall length of theanchor will preferably be between about 0.125″ and about 2″ with athickness between about 1/32″ and about 0.1875″. The device willpreferably be between about 0.0625″ and about 0.75″ wide. The arc of theanchor used from the tube will preferably be between about 5° and about320°. The diameter of the suture hole approximates, in some embodiments,the diameter of the suture used.

Staple Anchor Deployment Device

FIGS. 78A-78E depict embodiments of a staple anchor deployment device2500. The anchor 2505 can be cut from a half tube 2510. The other half2515 of the tube can be used to in deployment to secure the anchor 2505while be directed to an anchor site. The tube can allow for a breastneedle 2520 to fit inside. The needle 2520 can then create a path to theanchor site. There is preferably a tapered sheath 2525 over the deviceto cover the anchor 2505 until at desired location. Once at the desiredlocation, the outer sheath 2525 will be pulled slightly, allowing theanchor 2505 to be exposed enough to grab into the tissue. The outersheath 2525 and needle 2520 may then be removed leaving the anchoringdevice and remaining tube. The suture 2530 may then be pulled at theexit hole 2535 to disconnect the lower portion of the tube from theanchor itself. Once the anchor 2505 is disconnected from the tube, thetube may be removed. The anchor is then secured by pulling slightly tosecure into the fascia.

The delivery system is preferably wide enough, in some embodiments, toencompass the anchor, and, in some instances, is between about 0.0625″and about 0.75″. The length of the delivery system is preferably enoughto obtain desired delivery location, which, in some embodiments, isequal to or greater than about 0.25″.

Supraareolar Device

FIG. 79 depicts embodiments of a supraareolar device 2550. The device2550 can include four anchor springs 2555. The breast needle willpreferably be driven up into the breast from the bottom exit hole 2560.The needle will be directed up around and supraareolar. Then the needlewill come around the other side of the breast, exiting out the entrancehole as if to create a circular path around the nipple. Each of the fouranchors 2550 will be deployed through the circular path. In someembodiments, the top two anchors 2550 will carry supraareolar support,and in certain embodiments, the second two will support the sling 2565.

The length of the device 2550 is greater, in some embodiments, than thecircumference of the areola and, in certain embodiments, is less thanthat of the breast.

Sling Positioning Procedure

FIG. 80 depicts embodiments of a sling positioning procedure. Thisprocedure will allow the sling 2600 to be repositioned without having torun a suture through the anchor loop. In some embodiments, control ofthe lateral part of the breast tissue is obtained through a lateralanchor hole 2605 and control of the medial part of the breast tissuethrough a medial anchor hole 2610. For modification, the 3-exit holeprocedure will have the addition of a longer suture loop to the anchorneedle. Instead of pulling the suture through the anchor, the anchorwill leave an access suture that will run the anchor loop afterpositioning is deemed suitable.

Belt Buckle

FIG. 81 depicts embodiments of a belt buckle securing device 2650. Thebelt buckle suture securing device 2650 is one that will allow movementof the implant within the breast tissue. One end 2655 of a suture 2660is connected to two loops 2665, 2670. The end of a second suture 2675 isthen wound though the two loops 2665, 2670. Once the device is in theappropriate location, the second suture 2675 can be pulled tight toobtain a friction fit connection. This can be done remotely from an exitpoint.

The material of the ring, or loop, is preferably made of an implantablegrade resorbable or non-resorbable polymer and/or metal material,including but not limited to, Polypropylene, Polyester, Nylon, PEEK,Polyurethane, Polycarbonate, Titanium, and Stainless Steel. The ring orloop may have an ID of about 0.015″ up to about 0.25″ and a diameterfrom about 1/32″ to about 0.0625″.

Variable Durometer Spring

Incorporating a spring of variable durometers can allow a more securerange of movement. The lower durometers spring would allow for every daymovement. Incorporating the higher durometers would ensure that therewould be a buffer if high impact occurs. This would give relief to theanchor point and would allow that the suture not create a shock load.The durometers variations could include parallel variations or stepvariation, having one durometers next to another rather than along side.

The materials can include an implantable grade resorbable ornon-resorbable polymer and/or metal material, including but not limitedto, Polypropylene, Polyester, Nylon, PEEK, Polyurethane, Polycarbonate,Titanium, and Stainless Steel. In some embodiments, the two componentsmay be any combination of the above said materials or the same material.In some embodiments, the durometers of the two components aredissimilar. The varying durometers may run, in some embodiments,concentric to each other, or on top of each other.

Recapturing Device

The recapturing device would allow the anchor to be relocated during aprocedure if the anchor position was too superior. The recapturingdevice would be one that can be fed up through the exit point along thebottom of the anchor or where the anchor meets fascia. By being planar,parallel, and larger in diameter than the anchor, the component is ableto be slid under the anchor and lifted to release the anchor from thefascia for repositioning.

The material of the recapturing device is preferably made of animplantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Thewidth and length of the device should be, at minimum, about 0.005″greater than the width and length of the anchor extracted, and greaterthan or equal to about 0.75″, depending on the area of extraction andthe size of implant. The thickness of the device should be, in someembodiments, between about 0.015″ and about 0.25″.

Angled Anchor Deployment

FIG. 82 depicts embodiments of an angled anchor deployment. Whiledeploying the anchor within the fascia, orientation of the anchor 2600becomes critical. The anchor 2600 may be deployed superiorly parallel tothe fascia plane. This will allow the anchor 2600 to grasp the fasciaor, depending on the anchor type, sit within the adipose flush to thefascia. It is also possible to orient the anchor 2600 so that it is notlinear with the suture 2605, but rather angled to the suture 2605. Whiledeploying the anchor 2600 into the anchor site, the anchor 2600 may thenbe turned approximately 90° or parallel or perpendicular to the musclefibers depending on the anchor design. Depicted in FIG. 82, anddesignated as A is a perpendicular deployment of anchors. Designated asB is a parallel deployment of anchors, and designated as C is aposterior directed deployment of anchors.

In some embodiments, deployment of the anchors are dependent, in someembodiments, on the anchor used, and in certain embodiments, the anglewill be any angle perpendicular and parallel to the angle of the chestwall up and down, or left to right.

Profiled Spring

FIGS. 83A-83B, 84A-84B, and 85A-85B depict embodiments of profiledsprings. The profiled spring 2650 is one that is extruded and insertedinto the braid for the suspension of the device. By profiling the springit allows for less outer surface area in which the component maycontract more allowing for greater extension. There are straight andhelical extrusions allowing for varying deformation.

In some embodiments, the diameter (or cross-sectional dimension) of thespring will be between about 0.015″ and about 0.325″. The length of thespring will preferably be between about 1/16″ and about 6″. The helicalcomponent will preferably have between about 1 and about 60 revolutionsper inch.

Progressive Knot Pusher

The progressive knot pusher would allow the device to be installed andproperly fixed by deploying a series of previously tied knots at aspecified distance within the breast. This would allow for securing ofthe sling on either side of the breast at the anchor points. This wouldensure that the sling does not rotate, in addition, to the suture notcutting through the tissue. The knot pusher would be a polymer tube withinterval slits for the knots. Once the device is as the desiredlocation, the suture that is fed within the tube may be pulled,releasing the series of knots to secure the device.

The material of the pusher is preferably made of an implantable graderesorbable or non-resorbable polymer and/or metal material, includingbut not limited to, Polypropylene, Polyester, Nylon, PEEK, Polyurethane,Polycarbonate, Titanium, and Stainless Steel. The length of the pusherwill preferably be sufficient to reach the final knot location from theoutside of the body.

Interrupted Lumen

FIGS. 86A-86C depict embodiments of an interrupted lumen 2700. Theinterrupted lumen 2700 would allow for an anchor delivery system to runalongside the breast needle. A polymer lumen 2705 would be manufacturedto slide over the breast needle 2710 and would contain the anchor at thetip 2715. Approximately halfway down the needle 2710 the lumen 2705would be interrupted and the breast needle would exit, however, thelumen 2705 would continue alongside the breast needle 2710. At thispoint the anchor holding device 2720 would run down the middle of thelumen 2705. The top portion 2725 of the anchor holding device 2720 wouldsit on the outside of the lumen 2705 that is over the breast needle 2710at the tip covering the anchor. The breast needle 2710 and device 2720would be inserted into a desired location. Once there, the anchorcovering device 2720 could be slid down, advancing or revealing theanchor to the tissue. Then the breast needle 2710 may be removed leavingthe anchor in position.

The material of the sheath, slide, and other components is preferablymade from a combination of an implantable grade resorbable ornon-resorbable polymer and/or metal material, including but not limitedto, Polypropylene, Polyester, Nylon, PEEK, Polyurethane, Polycarbonate,Titanium, and Stainless Steel. The length of the sheath should, in someembodiments, be sufficient to allow the tip to reach the desired anchorlocation but still have the interrupted portion of the lumen outside thebody. This should be between about 0.5″ and about 30″. The Sheath lengthshould preferably be long enough to cover at least a portion of, andpreferably, the entirety of, the anchor, but preferably not to exceed itby more than about 2″. The ID of the sheath should preferably be greaterthan the outer diameter of the needle used but not more than about0.125″ larger. The length of the lumen connection should be betweenabout 0.125″ and about 5″.

Attached Lumen

FIGS. 87A-87C depict embodiments of an attached lumen delivery system2750. The attached lumen delivery system 2750 is one that has addedrigidity due to the addition of polymer loops 2755 at the distal end ofthe device. The loops 2755 are wrapped around the lumen and the breastneedle to keep them together during deployment. The lumen contains theanchor at the tip. The anchor cover is controlled from the exit point.The breast needle is inserted into the breast up to the desired anchorposition. Once at the right location, the anchor cover is pulled offusing the controller that exits out of the breast. The breast needle isthen pulled out, leaving the anchor in place. The lumen is attached tothe breast needle using a series of loops 27555.

The material of the sheath, slide, and other components is preferablymade from a combination of an implantable grade resorbable ornon-resorbable polymer and/or metal material, including but not limitedto, Polypropylene, Polyester, Nylon, PEEK, Polyurethane, Polycarbonate,Titanium, and Stainless Steel. The length of the sheath shouldpreferably be sufficient to allow the tip to reach the desired anchorlocation but still have the interrupted portion of the lumen outside thebody. This should preferably be between about 0.5″ and about 30″.

The Sheath length should preferably be long enough to cover thenentirety of the anchor but, in some embodiments, not to exceed it morethan about 2″. The ID of the sheath should be greater than the OD of theneedle used, but, in some embodiments, not more than about 0.125″larger. The length of the lumen connection should be between about0.125″ and about 5″. The diameter of the loops should preferably beapproximate to the diameter of the needle used. The length of the loopshould preferably be between about 0.015″ and about 1″, depending on thescale of device used.

Tubular Spring

FIG. 88 depicts embodiments of a tubular spring 2800. Rather than havinga profiled spring, the tubular spring 2800 would be inserted into thesuture 2805. The spring 2800 would be a tube that is hollow inside.Therefore when the spring 2800 is extended it will collapse into thecenter.

In some embodiments, the material of the suture components is preferablymade from an implantable grade monofilament or multifilament resorbableor non-resorbable polymer and/or metal material, including but notlimited to, Polypropylene, Polyester, Nylon, PEEK, Polyurethane,Polycarbonate, Titanium, and Stainless Steel. The spring component ispreferably made from an implantable non-resorbable polymer including butnot limited to a flexible silicone.

The outer diameter of the spring should preferably be able to fit withinthe spring center when fully expanded, but larger than the innerdiameter of the suture when relaxed. The OD of the spring may be betweenabout 0.002″ and about 1″ and the wall thickness between about 0.0001″and about 0.075″. The length of the spring should be between about 0.01″and about 6″.

Slide Sheath Deployment System

FIGS. 89A-89C depict embodiments of a slide sheath deployment system2850. The slide sheath deployment system 2850 would be one that has asyringe-like base. The outer sheath 2855 of the syringe would beattached to a long lumen 2860. This lumen 2860 would have a slit 2865 atthe end in which the suture 2870 that is attached to an anchor canslide. The inner sheath 2875 of the syringe like component would also beattached to an inner lumen 2878. This inner lumen would slide throughthe outer lumen and contain an anchor 2880 at the end. The anchor 2880at the end would be connected to a piece of suture 2870 at the tip. Thissuture would be free to move due to the slit in the outer lumen. Fordeployment, the inner lumen would slide over the breast needle 2885.Once at a desired location within the tissue, the inner lumen would bepushed forward, therefore allowing the outer lumen to release the anchor2880 and allow for the suture to easily slide through. Once the anchor2880 is in place, the deployment portion of the device may be removed.

The material of the sheath, slide, and other components is preferablymade from a combination of an implantable grade resorbable ornon-resorbable polymer and/or metal material, including but not limitedto, Polypropylene, Polyester, Nylon, PEEK, Polyurethane, Polycarbonate,Titanium, and Stainless Steel. The slit for the suture is preferablygreater or equal to the diameter of the suture 2870, and is, in someembodiments, equal to or less than about 0.0125″. The length of the slitwill preferably be between about 0.015″ and about 3″. The overall lengthof the device will preferably be such that the syringe component isoperative outside the body when the tip of the device is at the desiredanchor location.

Corkscrew Deployment Device

FIGS. 90A-90B depict embodiments of a corkscrew deployment device 2900.The corkscrew deployment device 2900 is one in which the anchor 2905 isset at the 2910 tip of a corkscrew 2915. The corkscrew 2915 is setinside a deployment lumen 2920. The anchor 2905 at the tip would be onethat is ring-like with an umbrella of barbs 2925. The anchor 2905 wouldalso have a suture attachment 2930. The lumen 2920 would have an openingslit 2935 at the end exposing the corkscrew once at the desired locationwithin the tissue. At that location, the corkscrew 2915 would be turnedinto the fascia. This turning motion would allow the suture 2940 to besewed into the fascia for several throws. Once the corkscrew 2915 isfully deployed, turning of the corkscrew in the opposite direction wouldrelease the device. The barbs 2925 on the anchor 2905 would bite intothe tissue and secure it place, leaving the suture loops in the fascia.

The material of the sheath, slide, and other components is preferablymade from a combination of an implantable grade resorbable ornon-resorbable polymer and/or metal material, including but not limitedto, Polypropylene, Polyester, Nylon, PEEK, Polyurethane, Polycarbonate,Titanium, and Stainless Steel. The suture may be of the above materialsin a monofilament or multifilament. The outer diameter of the corkscrewis preferably between about 0.015″ and about 3″, dependent on thelocation of deployment. The diameter of the corkscrew rod is less thanone-third of the overall diameter. The corkscrew preferably hassufficient revolution, so as to thread the suture at a width of thesuture diameter from each other. The anchor preferably has an innerdiameter, so as to securely fit on the tip of the corkscrew rod. Thelength of the sheath cut is preferably sufficient to expose the tip ofthe anchor and deploy it. The overall length of the sheath is preferablysufficient to reach to the anchor site while maintaining control fromout of the exit point. The inner diameter of the sheath is preferablygreater than the diameter of the overall corkscrew, but is preferablysmall enough to maintain control of the corkscrew.

Corkscrew Plate

FIG. 90C depicts embodiments of a corkscrew plate 2950. The corkscrewplate 2950 is one that the corkscrew device 2900 sutures around. Thisplate 2950 would have a path for the corkscrew 2915 to cycle, leavingthe suture 2940 behind and would allow a more solidified anchor to beplaced in the body. The plate 2950 would be deployed above the fascia,allowing the suture loops to penetrate the fascia.

The material of the components is preferably made from a combination ofan implantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Thewidth of the plate 2950 is preferably greater than the outer diameter ofthe corkscrew 2915. The length of the plate 2950 is preferably betweenabout 0.015″ and about 3″ dependent on the location on implantation. Thetop and bottom portion of the plate may or may not be flat.

Barbed Multifilament Suture

FIG. 91 depicts embodiments of a barbed multifilament suture 3000. Thebarbed multifilament suture 3000 is one that has an insertion of barbs3005 down the center of the braid and is capped by an anchor tip 3010.This allows the barbs 3005 to puncture through the side of the braid andcatch the skin. This suture 3000 could be fed down the center of adeployment device, allowing the tip of the suture to direct the deviceand be deployed.

The material of the components is preferably made from a combination ofan implantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel.

Umbrella Suture

FIG. 92 depicts embodiments of an umbrella suture 3050. The umbrellasuture 3050 is a suture that has a polymer tip 3055. The suture 3050 isbound to the polymer center. The polymer tip is pointed at the end 3060for directing through tissue and separating tissue as it is advanced. Atthe base 3065 of the polymer tip 3055, there are barbs 3070 that extendout into the shape of an umbrella. The barbs 3070 are directed as toeasily be inserted if suture is directed with the tip advancing first,however, if pulled in the opposite direction, the barbs catch the fleshand secure into the tissue.

The material of the components is preferably made from a combination ofan implantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel.

Umbrella Deployment Device

Some embodiments provide for an umbrella deployment device. Thedeployment device would utilize the umbrella suture. The suturepreferably includes a sheath over the barbs. A sheath may be placed overthe barbs and sit against the lip of the tip, allowing the suture to bepushed inside the breast. Once at the desired location within thetissue, the sheath may be removed, exposing the barbs so that they maybe secured in the tissue.

The material of the components is preferably made from a combination ofan implantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Theinner diameter of the deployment device preferably is larger than thelargest diameter of the anchor but preferably equal to or less thanabout 0.5″ than the largest diameter of the anchor. The suture and tipare preferably bonded by, but not limited to, material additive, heatset, friction or shrink fit, and plasma bonding.

Advancing Corkscrew

FIG. 93 depicts embodiments of an advancing corkscrew 3100. Theadvancing corkscrew 3100 would be one with two distinct varying pitchand angles springs that are either concentric or non-concentric in orderto create an offset during installation. In some embodiments, forexample, the corkscrew includes a larger diameter spring 3105 and asmaller diameter spring 3110. The larger diameter spring 3105 wouldpreferably enter the tissue first in order to create a larger bite fortracking into the smaller diameter spring. This would allow for betterfeed into position.

Hanger

FIGS. 94A-94B depict embodiments of a hanger anchor 3150. The hanger3150 is a resorbable or non-resorbable rod-like anchor that is attachedperpendicularly to suture in the center 3155 of one side 3160 of a rod3165. One end 3170 of the shaft is pointed to act as a guide in feedingup through the breast. Separated from the point, and shown approximatelyone-third down from the point, the cross-sectional shape of the shaftchanges and is representative of a “D” encompassing less than, or half,the diameter of the original cross-section. Then, halfway down theshaft, the “D” shape has a ring 3175 attached to it for sutureattachment.

The remaining portion of the shaft then resumes the “D”-shape. This “D”shape has multiple advantages. First, it allows the suture to liealongside the anchoring device during insertion inside the breast,without increasing the overlying sheath diameter in order to accommodatethe suture. Second, the flat portion of the “D” will lie perpendicularlyto the force of pull within the fascia plane allowing for heightenedsupport.

A second version (FIG. 94B) of the hanger 3150 does not contain anadditional ring 3175. Rather, the “D” shape is still maintained fortwo-thirds of the device; however, less than half of the cross-sectionalarea is removed allowing for more mass to be maintained. Instead ofhaving the ring 3175, there is a hole 3180 in the center of the hangerthat runs parallel with the suture and perpendicular to the overallshape of the device. The hole 3180 is dual diameter with a largerdiameter at the top of the device and a smaller one at the bottom. Tosecure the suture to the second version, a knot is tied in the suture.The larger diameter of the knot is to rest in the larger diameterportion of the hole, and the remainder of the suture is fed through thesmaller hole. The suture can then be bonded in the larger diameter hole.

The material of the components is preferably made from a combination ofan implantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Thelength of the device is preferably greater than the width. The width ispreferably greater than the diameter of the suture. For version 1 (FIG.94A), the inner diameter of the hole preferably is greater or equal tothe diameter of the suture. For version 2 (FIG. 94B), the smaller holepreferably is approximate to the diameter of the suture. The largerdiameter hole preferably is great enough to hold the width of the suturetied in chosen knot.

Braid Overlay Corkscrew

The Braid Overlay corkscrew 3200 is a corkscrew-shaped device that maybe inserted into the fascia to apply the suture in a stitched fashion.The suture 3205 is applied to the corkscrew 3210 prior to insertion.This is done by feeding the corkscrew 3210 down the center of the suture3205. At the end of the suture 3205, the anchor 3215 will preferably beattached to the suture 3205, and the anchor 3215 will sit on the end ofthe corkscrew 3210. The anchor 3215 may or may not be used to drive intothe tissue and fascia. Once the corkscrew 3210 is stitched into thetissue, the corkscrew 3210 is then removed by driving or rotating it inthe opposite direction. By reversing the direction, the corkscrew 3210will back out leaving the suture in place. This is aided by the factthat the anchor 3215 has a prong 3220 flange on the end that will secureinto the tissue and allow the suture to stay in place and not back outwith the corkscrew 3210.

The material of the components is preferably made from a combination ofan implantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Theinner diameter of the suture is preferably large enough to easily slideover the corkscrew.

Leaf Anchor

FIG. 96 depicts embodiments of a leaf anchor 3250. The leaf anchor 3250is one that has one or more spear-shaped prongs 3255 around the tip 3260of the anchor 3250. During deployment, leaves of the tip 3260 arewrapped around the suture that is attached to the anchor 3250. Oncedeployed, these spear-like prongs 3255 spring out and secure into thefascia perpendicularly to the pull. One or more of these may be appliedaround the anchor tip 3260. The prongs 3255 are attached via a slenderattachment point that will allow deflection and perpendicular placementto the head of the anchoring system.

The material of the components is preferably made from a combination ofan implantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Theinner diameter of a ring 3270, through which the suture may pass, on oneend of the leaf anchor preferably is greater than that of the sutureunder radial compression.

Umbrella Anchor

FIG. 97 depicts embodiments of an umbrella anchor 3300. The umbrellaanchor 3300 is one that is shaped like an umbrella with prongs 3305pointing in the a direction opposite than that of insertion. A tip 3310of the anchor 3300 is used to drive and separate the tissue as theanchor 3300 is advanced therethrough. In some embodiments, a sheath isapplied over the anchor tip. Once at a desired location within thetissue, the sheath is removed exposing the anchor. The anchor can thenbe pulled in the opposite direction of insertion. Once pulled, theprongs 3305 on the umbrella anchor 3300 then deploy outward grabbingonto the tissue.

The material of the components is preferably made from a combination ofan implantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel.

Washer Anchor

FIGS. 98A-98B depict embodiments of a washer anchor 3350. The washeranchor 3350 is an anchor created to adapt to the end of the corkscrewdeployment system. The washer anchor 3350 is attached to the suture3355. The anchor is a circular disk 3360 that is contractible, to have afirst cross-sectional dimension in a compressed state (FIG. 98A), and isexpandable, to have a second cross-sectional dimension (FIG. 98B),greater than the first cross-sectional dimension, in an expanded state.The washer is created to be deployed under the fascia. When pulledperpendicularly to the plane, the washer 3350 is expanded created alarge surface area for pull through resistance. Prior to deployment, thewasher wraps around the suture 3355 until it is deployed at the desiredlocation.

The material of the components is preferably made from a combination ofan implantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Thediameter of the disk is preferably greater than the diameter of theneedle that is used to puncture the fascia. In some embodiments, thethickness is between about 0.00001″ and about 0.3″

T-Bar Anchor Support

FIG. 99 depicts embodiments of a T-bar anchor support 3400. The T-BarAnchor support 3400 is a rod-like component that runs perpendicular tothe suture at varying distance from the anchor tip. The anchor support3400 will have a suture attachment point 3405 (which, in FIG. 99, isdepicted as a hole) at the center 3410. During deployment, the anchorsupport 3400 is turned parallel alongside the anchor. Once the distalanchor is deployed, the suture is pulled back in the opposite directionto engage the anchor support rods. The anchor supports 3400 then turnperpendicular to the suture and allow for additional support within thetissue. In some embodiments, the attachment point 3405 comprises a hole,and in certain embodiments, the hole can have a plurality of internaldiameters. For example, as depicted in FIG. 99, the hole can include asmaller hole 3415, having a smaller diameter, and a larger hole 3420,having a larger diameter.

The material of the components is preferably made from a combination ofan implantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Thelength of the device is preferably greater than the width. The width ispreferably greater than the diameter of the suture. The smaller hole ispreferably approximate to the diameter of the suture. The largerdiameter hole is preferably great enough to hold the width of the suturetied in chosen knot.

Fascia Puncture Deployment System

FIG. 100 depicts embodiments of a fascia puncture deployment system3450. This deployment system 3450 is created specifically to locate andpenetrate the fascia plane. The deployment system 3450 is inserted inthe exit-hole consisting of a blunt needle with a sheath. The needle isslid up to the desired fascia plane location. The blunt needle issimilar to a tipped hypotube in which a blunt tip shaped sheath isplaced at the end. Therefore, once at the fascia plane, the blunt tipwill not puncture through. Once the fascia plane is located, anothersharper needle 3455 can be pushed through the hypotube 3460, out theblunt end 3465, and into the fascia. The sharp needle 3455 would havecurvature as to allow angled deployment. Once punctured through thefascia, the sheath may then be slid through the fascia layer acting as aport. The needle 3455 may then be removed and the anchor may then beinserted under the fascia layer, leaving the suture exit through thefascia and into the tissue.

The material of the components is preferably made from a combination ofan implantable grade resorbable or non-resorbable polymer and/or metalmaterial, including but not limited to, Polypropylene, Polyester, Nylon,PEEK, Polyurethane, Polycarbonate, Titanium, and Stainless Steel. Thelength of the device is preferably greater than the width. The length ofthe device should preferably be sufficient to allow the inner needle toreach through the desired location on the fascia plane while allowingcontrol out of the exit point.

Tree Branch

FIG. 101 depicts schematic representations of embodiments of a device3500 that can be used alone or in combination with other embodimentsdescribed herein. The material of the components can be made from acombination of an implantable grade resorbable or non-resorbable polymerand/or metal material, including but not limited to, Polypropylene,Polyester, Nylon, PEEK, Polyurethane, Polycarbonate, Titanium, andStainless Steel. The length of the device may be greater than the width.This shape will allow for the device 3500 to be inserted into the centerof a braided suture and when pulled back, the branches 3505 will spreadout away from a central portion 3510 and pierce the suture to form abarbed suture. This device 3500 can be made long and cut down to anyappropriate size. The amount of barbs, or branches 3505, shown willdictate the amount of grip the device will have. The diameter of themain branch is preferably less than the inner diameter of the suture atfull expansion.

Y-barb

FIGS. 102A-102D depict embodiments of a y-barb anchor 3600 that can beused in connection with other embodiments and methods provided herein.FIG. 102A is a perspective view of the anchor 3600. The anchor 3600 hasa neck 3605 that extends from a central portion 3610 of the anchor andthat can include a slight taper 3615 at a distal end 3620 of the neck3605. The slight taper 3615 can be used to facilitate advancement of theanchor 3600 through tissue by providing a decreased cross-sectionalmeasurement, relative to a cross-sectional measurement of the neck 3605,that can separate tissue as the anchor moves through the tissue. Theneck 3605 can include, as depicted shown in the bottom view of FIG. 102Band the top view of FIG. 102D, a plurality of ridges 3625 along one ormore sides that can increase the gripping capabilities of the anchor3600.

The anchor extends proximally from the center portion 3610, in someembodiments, with two laterally extending legs 3630. The legs 3630 arepreferably constructed such that as the anchor 3600 is advanced distallythrough tissue, the distal end 3620 separates tissue, and the legs 3630are slightly deflected towards each other. When the anchor 3600 ispositioned in a desired location, the anchor 3600 is drawn slightlyproximally, and the legs are directed apart from each other and functionas a barb, or anchor, in the tissue, limiting proximal withdrawal.Although the anchor 3600 is depicted as having two legs 3630, in someembodiments, the anchor 3600 can have more or less than two legs 3630.For example, in some embodiments, the anchor 3600 can have three, four,five, or six legs 3630. In some embodiments, the anchor 3600 can havemore than six legs 3630. In some embodiments, the portion of the anchor3600 distal to the central portion 3610 can include legs for engagingtissue, and in some embodiments, these legs 3630 can be oriented inopposition to the proximally positioned legs 3630 such as those depictedin FIG. 102A-102D. FIG. 102A-102D depict the anchor as extendingsubstantially along a plane, in which the legs 3630 also extend. In someembodiments, the legs 3630 can extend out of or through a plane thatcontains a remaining portion of the anchor, as described above inconnection with other embodiments of anchors.

In some embodiments, the anchor 3600 includes at least one of a distalaperture 3635 and a proximal aperture 3640, as shown in FIG. 102D. Theseapertures 3635, 3640 can be used to attach the anchor to a suture. Insome embodiments, a suture extending distal to the anchor 3600 isattached to, passes through, or coupled to distal aperture 3635, and insome embodiments, a suture extending proximal to the anchor 3600 isattached to, passes through, or coupled to proximal aperture 3640. Insome embodiments, the suture can extend from proximal to the anchorthrough the proximal aperture 3640, along the anchor 3600, pass throughthe distal aperture 3635, and extend distal to the anchor 3600. Thesuture, can have securing devices along its length to limit movement ormigration of the anchor 3600 along the suture. In some embodiments, aknot can be tied in the suture on either side of the apertures 3635,3640 to limit or restrict movement of the anchor along suture. In someembodiments (not depicted), the anchor can have a central lumenextending, for example, with a proximal opening at the proximal end to adistal opening at the distal end. In some embodiments, the suture canextend through the central lumen, and the suture can have securingdevices, knots, or the like, for limiting axial movement of the anchoralong the suture.

In some embodiments, the suture, as a woven or braided element can bewoven or braided over the anchor such that the anchor 3600 is, aftermanufacturing, effectively an integral part of the suture. In theseembodiments, the suture can be provided with one or more anchors forinsertion in the body.

Superior Entry

FIGS. 103A-103S depict embodiments of devices for and methods ofelevating, or lifting, soft tissue through introduction of the devicesthrough a superior entry. Depicted is an exemplary procedure forelevating breast tissue, but the same or similar devices and methods canbe used to elevate other soft tissue. For example, the devices andmethods relating to superior entry can also be used in connection withelevating tissue of the buttocks, face, etc.

As described herein, superior generally refers to a direction that isrelatively cephalad or towards the head while inferior generally refersto a direction that is relatively caudal or toward the feet. Asuperior-inferior axis of an anchor support line may be inclined withrespect to or substantially parallel with respect to the patient'slongitudinal (cephalad-caudal) axis. Generally the superior-inferioraxis will be within about 85 degrees, often within about 65 degrees, andin some applications within about 45 degrees of the longitudinal axis ofthe patient, measured in at least one of the anterior-posterior ormedial-lateral planes, depending on the desired cosmetic result. In someimplantations, the angle will be no more than about 25 degrees.

Similarly, medial generally refers to a direction closer to the midlineof the body with respect to a lateral location; a medial-lateral axiscould be transverse or substantially transverse with respect to thepatient's longitudinal axis, or angularly deviated such as within about85 degrees, 65 degrees, 45 degrees, 25 degrees, or less with respect toan axis transverse to the longitudinal axis of a patient.

In some embodiments, as depicted in FIG. 103A, the patient is markedpreoperatively with a superior entry point 3700 and medial 3702 andlateral 3704 exit points. At the superior entry point 3700, a superiorport 3706 is inserted, for example, with a trocar and port dilator 3708.FIG. 103B depicts removal of the trocar and port dilator 3708, leavingthe superior port 3706 extending transcutaneously into the patient. Asuture or anchor needle 3710 is advanced through the superior port 3706,through the patient and exits at the lateral exit point 3704.

FIG. 103C illustrates a first end 3714 of a superior sling 3712 beingadvanced, by the needle 3710, through the superior port 3706, and out ofthe patient at the lateral exit point 3704. The first end 3714 of thesuperior sling 3712 is advanced while keeping, at this point, a slingportion 3718 of the superior sling 3712 from entering the superior port3706.

In FIG. 103D, the needle 3710 is advanced through the superior port 3706and exits the patient at the medial exit point 3702. FIG. 103Eillustrates that a second end 3716 of the superior sling 3712 has beenadvanced, by the needle 3710, through the superior port 3706 and out ofthe patient at the medial exit point 3702. The second end 3716 of thesling 3712 is advanced, in some embodiments, while keeping a slingportion 3718 of the superior sling 3712 from entering the superior port3706.

With the sling portion 3718 extending out of the superior port 3706, andthe first 3714 and second ends 3716 of the superior sling 3712 extendingthrough the superior port 3706 and respectively out of the lateral 3704and medial exit point 3702, the first 3714 and second ends 3716 of thesuperior sling 3712 can be pulled to advance the sling portion 3718 intothe superior port 3706. As the first 3714 and second 3716 ends of thesuperior sling 3712 are pulled further, the sling portion 3718 advancesthrough the superior port 3706 and emerges from a distal end of the port3706, which is beneath the surface of the patient's skin. The first 3714and second ends 3716 of the superior sling 3712 can be further pulled tospread out the sling portion 3718, as depicted in FIG. 103F, whilekeeping the sling 3712 in a centered position between the lateral 3704and medial 3702 exit points. The superior port 3706 can then be removed.

The above steps provide introduction of a superior sling 3712, orsupporting member, within a contoured pathway that leads from thelateral exit point 3704 to the medial exit point 3702 through threesmall entries in the patient's skin. The depth of the sling portion 3718can be determined by the depth the superior port 3706 is advanced intothe patient.

FIG. 103G depicts advancement inferiorly of a needle 3720 and cannula3722 from the lateral exit point 3704 to an exit point 3724 at a base ofthe breast 3726. FIG. 103H illustrates removal of the needle 3720 fromthe cannula 3722 and advancement, through the cannula 3722, of a feederrod 3728 having, for example, a loop 3730 at a proximal end 3732 of therod 3728. A distal end 3736 of an anchor 3734 is coupled to the proximalend 3732 of the rod 3728, for example, through the loop 3730, and therod 3728 is further advanced through the cannula 3722, drawing thedistal end 3736 of the anchor suspension line 3734 through the cannula3722, as shown in FIG. 103I. The anchor suspension line 3735 carryingone or more inferior anchors 3734 is advanced through the cannula 3722until the distal end 3736 emerges from the distal end 3738 of thecannula 3722.

In the step depicted in FIG. 103J, the cannula 3722 is withdrawnproximally until the distal end 3738 of the cannula 3722 is adjacent theexit point 3724 at the base of the breast 3726. A desired location ofthe anchor suspension line 3735 including anchor 3734, within thecannula 3722, is determined, and the anchor 3734 is adjusted to thedesired location by measuring a first length of the distal end 3736 ofthe anchor suspension line 3735 extending out of the distal end 3738 ofthe cannula 3722 or by measuring a second length of the proximal end3740 of the anchor suspension line 3735 extending out of the proximalend of the cannula 3722.

FIG. 103K depicts removal of the cannula 3722 while leaving the anchorsuspension line 3735 in place. In this step, the anchor suspension line3735 and anchor 3734 is held in a substantially stationary position,while the cannula 3722 is withdrawn proximally from the patient throughthe lateral exit point 3704. Once the cannula 3722 is withdrawn from thepatient, the anchor 3734 can be drawn slightly proximally to ensureproper positioning and lift. If a problem exists with the positioning orplacement of the anchor 3734, the distal end 3736 of the anchorsuspension line 3735 can be pulled distally, and the anchor suspensionline 3735 can be completely removed from the exit point 3724 at the baseof the breast 3726. The procedure can then be repeated by advancing thecannula 3722 back into the patient for proper placement or positioningof the anchor suspension line 3735. A plurality of anchor suspensionlines 3735 can be inserted through each of the lateral 3704 and medial3702 exit points, and each can have a different path through the breast3726 such that a plurality of anchor suspension lines 3735 are disposedradially across the breast 3726, as depicted in FIG. 103L.

The next steps comprise coupling the anchor suspension line 3735 withthe superior sling 3712. FIG. 103M illustrates, at the lateral exitpoint 3704, the first end 3714 of the superior sling 3712 and theproximal ends 3740 of the anchors suspension line 3735 advanced throughthe lateral exit point 3704 being advanced through a suture loop 3744 ata base of a knot tube 3746. FIG. 103N depicts the first end 3714 of thesuperior sling 3712 and the proximal ends 3740 of the anchor suspensionline 3735 advanced through the lateral exit point 3704 being pulledthrough the knot tube 3746 by the suture loop 3744. Once they are pulledthrough the knot tube 3746, the suture loop 3744 is removed. The knottube 3746 is then advanced over the first end 3714 of the superior sling3712 and the proximal ends 3740 of the anchor suspension line 3735, anda distal end 3748 of the knot tube 3746 is advanced into opening of thelateral exit point 3704, as illustrated in FIG. 103O. The breast 3726 isthen lifted, and a distance D₁ between the sling portion 3718 and aninferior anchor 3734 is decreased (compared with D₂). In someembodiments, the breast 3726 is manually distracted, and in someembodiments, the breast 3726 can be distracted by pulling on theproximal ends 3740 of the anchor suspension line 3735. The proximal ends3740 of the anchor suspension lines 3735 are independently drawn at ahub 3750 of the knot tube 3746 and secured in position, for example,with a clamp. In some embodiments, the superior sling 3712 is clampedfirst. The same, or similar, steps are followed with the second end 3716of the superior sling 3712 and the proximal ends 3740 of the anchorsuspension line 3735 extending from the medial exit point 3702, asillustrated in FIG. 103P.

FIG. 103Q depicts the step of securing the superior sling 3712 with theproximal ends 3740 of the anchor suspension line 3735. The figuredepicts lifting the knot tube 3746 until the sutures 3754, or first end3714 of the superior sling 3712 and proximal ends 3740 of the anchorsuspension line 3735, are visible at the base of the knot tube 3746. Thesutures 3754 are clamped with, for example, hemostats 3752, and the knottube 3746 is removed. The sutures 3754 are tied together using astandard surgeon's knot, and the clamp 3752 is released. The knottedsutures 3754 are then drawn back into the tissue, as illustrated in FIG.103R. The same, or similar, procedure is followed with the other of theknot tubes 3746. The excess material from the superior sling 3712 andanchor suspension line 3735 is then trimmed and the openings at the exitpoints are closed, as illustrated in FIG. 103S.

The above-referenced methods and devices provide an inverted sling andanchor system that engages tissue in the lower portion of the breastwhere the tissue tends to be stronger and where the anchors will holdposition better, in some embodiments, than with superior anchorplacement. As described, multiple anchors may be attached to each end ofan upper sling to adjust tissue into position relative to thepretreatment ptosis. Upper breast fullness and lift is achieved in thesetechniques by moving the breast tissue toward the sterna notch.Additional movement of the nipple being repositioned is achieved bylifting the tissue associated and surrounded by the anchored tissue. Insome embodiments, the procedure will both accomplish (1) adjusting acenter of the tissue mass superiorly and (2) adjusting the nipple anglesuperiorly, and sometimes medially depending on the desired cosmeticresult. This could be accomplished by implanting at least a first anchorsupport line (which could be 2, 3, 4, or more anchor support lines) toelevate the tissue, and then implanting at least a second anchor supportline, along a different axis, to elevate or otherwise adjust the nippletrajectory.

The anchors as described above are made from bio-inert materials such asstainless steel, Nitinol or cobalt-chromium (NP35N) or polymers such aspolypropylene, nylon, PEEK or Teflon. They may be integral to thesuspension lines or mounted secondarily with single or multiple anchorsattached to each suspension line. As they are single directionengagement, they may be repositioned or removed if desired duringplacement. Some embodiments utilize anchors, suspension lines, and/orsutures depicted and described above.

As discussed above, the anchor lines may be dispensed through a sheathto protect the surrounding tissue and can be engaged superior to thenipple for maximum adjustability. The anchors may also be used inconjunction with an elastomeric or spring suspension line for loadabsorption or the anchor can be designed to absorb the excess loading.Additionally, this technique can be modified to eliminate, limit, orreduce use of, the anchor portion and utilize a continuous length sutureto create a loop at the top and bottom of the breast tissue where agathering of tissue both top and bottom would provide a force vectorsimilar to the discrete anchors described above. In some embodiments,the anchors can be attached to the suspension lines and about 2-4anchors would be attached to each line. In some embodiments, a systemcould include at least 1, 2, 3, 4, 5, 6, or more suspension lines. For aB-cup sized breast, for example, two to four anchors could be in eachbreast depending upon how much lift is desired.

FIGS. 104A-104H depict embodiments of inserting the superior supportsuspension lines through two incisions. In FIGS. 104A-104B, a supportelement 3712 having one or more suspension lines 3714, 3716 is insertedinto a first incision 3704. FIG. 104B depicts the support element 3712inserted into the tissue and positioned between the first incision 3704and a second incision 3702 with a suspension line 3714, 3716, or suture,extending out of the patient from two ends of the support element 3712through the first 3704 and second 3702 incisions.

FIGS. 104C-104H depict a process similar to those described above withrespect to FIGS. 103A-103S of inserting anchors 3734 inferiorly throughthe breast tissue, securing the superior connection of the anchorsuspension line 3735 to the support element 3712, and trimming theexcess line following positioning of the knots under the patient's skin.FIG. 104H depicts the support element 3712 connected to four anchorsuspension lines 3735 that extend inferiorly into the breast tissue.

FIGS. 105A-105J depict embodiments of inserting the superior supportsuspension lines through a single incision 3756 which can be, forexample, in between, such as at or near the midpoint between previouslydescribed medial and lateral incisions. These embodiments can beperformed similar to those described previously with respect to aninferior approach. In some embodiments, introduction of the suspensionlines follow similar processes as described above with respect toembodiments described in FIGS. 103A-103S and FIGS. 104A-104H.

FIGS. 105A-105D depict introduction of a first anchor suspension line3735 through the superior incision 3756 and advancement of the anchor3734 through the breast tissue. As described with respect to embodimentsabove, the anchor suspension line 3735 can be advanced through an exitaperture 3724 toward the base of the breast. FIGS. 105E-105H depict thatthis procedure is repeated for a plurality of lines through additionalinferior exit aperture 3724′, and FIGS. 105I-105J depict securing of aproximal end 3758 of the plurality of lines 3735 to a support member3712 and introduction of the support member 3712 into the tissue througha port 3706. In some embodiments, introduction of the plurality of lines3734 can be performed through a port 3706, which can increase the depthof tissue into which the support member 3712 is ultimately placed. Asexplained above, in some embodiments, increasing the depth of thesupport member 3712 can limit or reduce the likelihood of a dimple orindentation created in the tissue after the procedure when the anchors3734 pull on the support member 3712.

Pull-Out Force Resistance and Surface Area Properties of Superior andInferior Anchors

In some embodiments, the pull-out force of an anchor is generallygreater near the top of the breast (superior) than at the bottom(inferior). Thus, in some embodiments, the force in an inferiordirection required to pull out the superior anchor (e.g., the supportelement or sling) exceeds the force in the superior direction to pullout the inferior anchor by at least about 2×, at least about 3×, atleast about 4×, at least about 6×, or even at least about 8× in certainimplementations. Not to be limited by theory, but in some embodimentshaving anchors with dissimilar properties, such as with a more robustsuperior anchor with respect to the inferior anchor, can be advantageousto reduce the risk of anchor pull-out as the superior breast tissuetends to have a softer, fat-like consistency while the inferior breasttissue tends to have a tougher, fibrous-like consistency. Using the sameanchors both superiorly and inferiorly that are configured to resistpull-out of the superior anchor could cause the inferior anchor tobecome visible, palpable, and/or cause dimpling.

The superior support element or anchor (e.g., the sling) has a firstsurface area that can be an inferiorly facing surface area. Each barb orother transverse aspect of the inferior anchors has a surface which hasa component facing in the superior direction. The sum of all of thesuperior facing surface areas on all of the support lines can beconsidered to be a second surface area. In some embodiments, the firstsurface area exceeds the second surface area by at least about 2×, atleast about 3×, sometimes at least about 5× and sometimes at least about10×.

In some embodiments, the top support load of the superior anchor (e.g.,the superior sling) will be distributed over a relatively large surfacearea, which can advantageously reduce potential shear forces as comparedto an anchor with a smaller anchoring surface area. In certainembodiments, the top load will be distributed over an area that is atleast about 1 cm², 2 cm², 3 cm², 4 cm², 6 cm², 8 cm², 10 cm² or more.

In some embodiments, the implanted system is free floating to someextent (e.g., not suspended to bone or cartilage) both superiorly andinferiorly to optimize natural motion of the tissue. The superior slingacts like a leaf spring under load, since the anchor support lines willbend the ends of the sling inferiorly (decrease the radius of curvatureof the sling). However, the radius of the sling will resiliently reboundonce the transient load is removed. In addition, the transverse elementsof each anchor could act like a small lever under load. The net effectis to dampen the effects of intermittent loading cycles toadvantageously preserve native tissue resiliency, look and feel, andcould also help avoid anchor pull out under high loads.

Minimally Invasive System as an Adjunct to Surgical Mastopexy

While the systems and methods described herein can be used as part of astand-alone minimally invasive tissue lift or mastopexy system, they canalso be used as an adjunct to a surgical mastopexy (or lift procedure ofany tissue other than breast tissue) to produce improved fullness, forexample, in the superior medial quadrant. Surgical mastopexies elevatenipple trajectory but often leave a mild concavity or flatness in thesuperior medial quadrant. In some embodiments, a patient requiringmastopexy can be identified, and a surgical mastopexy can be performedalong with implanting the minimally invasive system as described herein.The minimally invasive system implantation can occur concurrently (e.g.,while the patient is still in the operating room, on the same day). Inother embodiments, a patient that has previously had a surgicalmastopexy with suboptimal results could have the minimally invasivesystem described herein implanted as a revision or “tune-up” procedure.In some embodiments, the revision procedure of implanting the minimallyinvasive mastopexy system can occur within 1 day, 1 week, 2 weeks, 1month, 2 months, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years,5 years, or more of the surgical mastopexy procedure.

Materials & Construction

Elements of the support system can comprise a number of materialsincluding, without limitation, biocompatible polymers (e.g., ePTFE),intestinal sub-mucosal mesh, tendon, Gore-Tex®, and polypropylene.Materials can be monofilament, or multifilament, and can be braided,woven, or knitted. In some embodiments materials are absorbable (i.e.,biodegradable). In some embodiments, the materials comprise coatings orother agents that promote healing, reduce inflammation, or improvebiocompatibility.

In some embodiments, the use of biological materials can improve tissueinteraction with the device. Where a lack of tissue ingrowth orvascularization is a concern, the materials can be further modified byperforation, or by other treatments such as fixation with radiation,glutaraldehyde, heat or 1-ethyl-3-(3-dimethylaminopropyl)-carbodiimide(EDC), to improve porosity.

In some embodiments, the mesh material of the support member, forexample a sling or hammock, comprises a flexible, polypropylenemonofilament that resists weakening or degradation when implanted withina patient. One such material is Marlex. Other mesh and non-meshmaterials, can comprise, but are not limited to, synthetic biomaterials,allografts, homografts, heterografts, autologous tissues, materialsdisclosed in U.S. provisional application Nos. 60/263,472; 60/281,350;and 60/295,068; the contents of all of which are herein incorporated byreference in their entireties, synthetic materials (such as metallics,polymerics, and plastics) and any combinations thereof.

In some embodiments, the support member material will result in minimalor no reaction with body tissues and fluids and indefinitely retain itsparticular material characteristics and mechanical properties. Further,portions or all of the support member can be configured or fabricatedfrom a material to either promote or prevent tissue in-growth, or areresorbable.

In some embodiments, the support member, support member assembly orportions thereof, can have one or more substances associated therewiththrough processes such as coating, impregnation, or combinations ofthese processes. Examples of appropriate substances include, withoutlimitation, drugs, hormones, antibiotics, antimicrobial substances,dyes, silicone elastomers, polyurethanes, radiopaque markers, filamentsor substances, anti-bacterial substances, chemicals or agents, and anycombinations thereof.

The substances can be used to enhance treatment effects, reducepotential rejection by the body, enhance visualization, indicate properorientation, resist infection or other effects. For example, a substancesuch as a dye may be coated on one surface of a component of the supportsystem. The dye can provide the practitioner/surgeon with a visualindicator to aid in orienting the support member or suspension membersat the target site within the patient and to avoid undesirable twistsalong the length of the system. In some embodiments, one or morecomponents can be configured to be visualized transcutaneously. Asanother example, the system may be coated by the process described inU.S. Pat. Nos. 5,624,704; 5,756,145; 5,853,745; 5,902,283 and 6,162,487;the entire contents of which are hereby incorporated by reference.

It will be apparent to those skilled in the art that varying geometriesfor the components of the device will be useful. For example, certaindimensions of thickness, width, or length will be recognized as being ofparticular advantage. In addition, components that are woven, braided,wide or narrow can also provide particular support functions.

For example, as described above, in some embodiments the support membercomprises a “hammock” or “sling” shaped element. A sling or hammock canbe especially useful for supporting glandular tissues, such as breasttissue. In some embodiments, a hammock with dimensions of about 7 cm toabout 15 cm in length, and about 2 cm to about 5 cm in width, with apocket of about 0.5 to about 3 cm, provides effective tissue support. Insome embodiments, a hammock can have a length of about 10 cm, a width of2.5 cm and a pocket depth of about 1 cm. In manufacturing a hammock, theparticular shape can be formed by wrapping the material about aspherical or elliptical shaped mandrel, followed by heating and coolingthe mandrel to induce the material to conform to the shape of themandrel.

A sling (or hammock) can comprise first and second major surfaces, apair of end portions, and a support portion for placement in atherapeutically effective position relative to a physiologicalenvironment intended to be supported (e.g. the glandular tissue of thebreast). In some embodiments, the sling has a tension adjustment orcontrol member associated with the sling, for transferring slingadjustment forces from one portion of the sling to other portions of thesling such as the ends of a support portion of the sling. The memberaffords effective repositioning of the sling while avoiding undesirablepermanent deformation of the sling.

The support member can be substantially surrounded by a protectivesheath. The support member, tension control element, and sheath can bemade of biocompatible materials with sufficient strength and structuralintegrity to withstand the various forces exerted upon these componentsduring an implant procedure, and/or following implantation within apatient. In some embodiments, the protective sheath is constructed of amaterial that affords visual examination of the implantable supportmember material and that affords convenient passage of the assemblythrough tissue of the patient.

In some embodiments, a woven mesh with a predetermined pore or openingsize to permit tissue ingrowth can be used. The shape of the openings isnot considered limiting to the scope of the present disclosure, andsquare, rectangular, and/or round openings are useful. In someembodiments the size of the openings can vary, for example and withoutlimitation, from an area of at least about 0.1 mm2 to no more than about30 mm2. The arrangement of pores can vary throughout the device in orderto provide some areas with added porosity, or to provide more support.Some areas can comprise pores, while in other areas pores can be absent.The device can be produced from elastic materials, or alternatively canbe fashioned from relatively rigid materials.

In some embodiments, the mesh-like support member is woven from amonofilament line. Some monofilament lines are finished with a smoothsurface, while others are roughened during the manufacturing process.Roughening the surface increases surface area and thus increasesopportunities for tissue ingrowth throughout the surface interstices.

Roughening can be accomplished during the extrusion process where thematerial is flowing through the extrusion die hot thus creating adimpled surface. Other roughening methods include, without limitation,sanding, grinding, roll forming, laser etching, chemically etching, andspirally or radially scoring to a predefined depth with a cutting blade,laser, or other means. Examples of sanding may use a 5-100 grit sandpaper pulled across the material. This drags portions of the materialalong the longitudinal axis and leaves behind whiskers or microscopicbarbs that can also be effective to engage the tissue. A similar processcould be used with a grinding wheel. Grinding can be performed in aradial pattern, a helical pattern, or a combination of patterns. Rollforming allows for a predetermined shape or pattern to be pressed intothe monofilament, and can be performed either with a heated roll or atambient temperatures.

Laser etching allows for an inline process to be added to the formationof the monofilament. The laser can be angled or focused directlyperpendicular to the material. Chemical etching removes material at apredictable random pattern and a predefined depth based on chemicalstrength and length of contact with the material being etched. Othermaterials can be plasma etched to create a desired surface finish wherea chamber is pumped to a preset base pressure and gas is introduced anda radio frequency field is applied to the electrodes of the chamberproducing a glow-discharge plasma.

Knife scoring allows a partial cut to the material to a predetermineddepth leaving behind a ribbed monofilament material that will be moreflexible and allow tissue ingrowth to the cut sections. These cuts canalso be in a spiral patterning to allow a continuous cut throughout thematerial length. This also allows for tissue ingrowth.

In some embodiments, partially or completely absorbable materials areused, such that a component(s) can be absorbed over a period rangingfrom about 6 weeks to about 2 years. This allows the skin and othertissues to retighten and remodel, while otherwise being supported in adesired position. Other methods are also useful in remodeling ortightening the skin around the breast including, without limitation,forced scarring, use of laser, heat, and the like.

In some embodiments, the overall dimensions of the support memberassembly, including individual sheath, mesh element and tension controlmember, are effective to extend from the upper most connection pointdown partially encircling the lower portion of the breast and back up tothe upper most portion of the connection point, with additional lengthto account for the imprecision associated with the range of humananatomy sizes. In some embodiments, the support member has a length,width, and thickness of within the ranges of length: 8 cm to 16 cm,width: 1.0 cm to 6.0 cm and thickness: 0.10 mm to 1.0 mm. In addition,the length of the tension control element can be approximatelyequivalent to or slightly longer than the length of the support memberto tighten or loosen the sling after it is placed in the body.Alternative lengths, widths and thicknesses can also be used, dependingon the particular anatomical features of the individual patient, and thetissue(s) being supported.

In addition, the size of the resultant openings or pores, in supportmembers configured as a mesh, can be adapted to allow tissue in-growthand fixation within surrounding tissue. The quantity and type of fiberjunctions, fiber weave, pattern, and material type influence varioussling properties or characteristics. Non-mesh sling configurations arealso included within the scope of the invention.

As an example, and not intended to be limiting, the mesh can be wovenpolypropylene monofilament, knitted with a warp tricot. The stitch countcan be 10±1 courses per cm, and 5±1 wales per cm. In an exemplary mesh,the mesh thickness can be 0.6 mm.

The support system of the present disclosure is not limited by the needfor additional sutures or other anchoring devices, although such suturesand devices can be used if desired. The frictional forces createdbetween the system and patient tissue are effective to prevent movementand loss of tension once the system is properly located at the targetsite. As a result, the system remains securely in place, even whensubjected to various forces imparted on the tissue as will in thepatient during various activities.

The system is designed to remain within the body of a patient as animplant for a predetermined therapeutically effective amount of time.Implantation can be temporary or permanent. The system can benon-absorbable, absorbable or resorbable, including any combinations ofthese material properties, depending on the desired treatment. Forexample, portions of the system may be constructed of a bioabsorbablematerial designed to last for a predetermined period of time within thepatient. The general characteristics of the materials and design used inthe system will withstand the various forces exerted upon it duringimplantation (for example, frictional forces associated with tissueresistance) and after implantation (for example, normal activities,including walking, running, coughing, sneezing, and other “normal”activities).

The system as disclosed can be anchored to a variety of locations in thebody, including, but not limited to fascia, muscle, bone, ligament, andthe like. In addition, an anchor can further comprise an adjustmentdevice that permits the surgeon to adjust the tension on the suspensionmembers either at the time of implantation, or post-implantation. Theadjustment device can be a simple screw-like mechanism, around which anend of the suspension line is wrapped. Turning the screw in onedirection increases the tension on the line, while turning in theopposite direction decreases tension. In some embodiments, the tensioneris adjusted through a small incision using an endoscope or other likeinstrument, in combination with a tool designed to turn the tensioner.

In some embodiments the suspension members can be anchored to a singleattachment point. In some embodiments multiple attachment points areused. The elements of the devices can be elastic, or non-elastic asdesired. In some embodiments, a braided portion overlying an elastomericportion is used. In some embodiments, the braided portion is alsoelastomeric.

Design/Fabrication of Anchor, Mesh Sling System

FIGS. 106-107 shows a schematic of some examples of tools and devicesthat can be involved in the implantation of the anchor and sling supportsystem, of which details of further embodiments will be disclosed. Insome embodiments, one, two, or more of the tools and devices describedherein can be part of a system or packaged together as part of a kit.FIG. 106 schematically illustrates a needle 3802 that can be configuredto create a subcutaneous tissue pathway for the support element orsling. The needle 3802 can have any desired shape depending on thedesired clinical result. In some embodiments, the needle 3802 forms anarc of about 180 degrees. FIG. 107 illustrates an alternative needle1803 that forms an arc of about 270 degrees. In some embodiments, theneedle forms an arc of between about 120 and 330 degrees, between about180 and 270 degrees, or at least about 150, 165, 180, 195, 210, 225,240, 255, 270, 285, or 300 degrees in some embodiments, but less than360 degrees.

Referring back to FIG. 106, also illustrated is a needle 3720 that canbe disposed within a cannula 3722 to create a subcutaneous pathway 3800(dashed line) for one or more inferior anchors (not shown). In someembodiments, the needle 3720 is curved and having a radius of curvatureof between about 6″ and 12″, between about 8″ and 10″, or about 9″ insome embodiments. In some embodiments, the needle 3720 has a totallength of between about 6″ and 12″, between about 8″ and 10″, or about9″. Also illustrated is the a superior entry point 3704 and inferiorexit point 3724 that can be as previously described.

In some embodiments, an example of a system or kit includes one, two, ormore of the following items:

Trocar and port dilator for creating one or more superior ports

Superior port with one, two, or more lumens, to allow for insertion ofother instruments such as a superior support element Superior supportelement insertion tool, such as a curved needle for creating a tissuepathway for a superior support element (e.g., a sling)

Inferior anchor insertion tool, such as an elongate needle that may bedisposed within a cannula, for creating a tissue pathway for an anchoralong a generally superior-inferior axis

Elongate wire, such as a feeder rod, that can have a coupling elementsuch as a loop on the proximal and/or distal end for releasableconnection to the inferior anchor line

Knot tube having a hub for releasably housing an end of the inferioranchor lines therethrough

One, two, or more clamps, such as hemostats for releasably holding anend of the inferior anchor lines, such as when running through the knottube

Superior support element, such as a sling assembly, including anelongate, flexible sling that can be operably connected to a firstsuture for connection to a first inferior anchor line and a secondsuture for connection to a second inferior anchor line

One, two, three, four, or more anchor lines, each having one, two,three, or more inferior anchors

Connector to connect the sling assembly and anchor line, such as aretainer—wedge device configured to maintain a desired suture tension

Adjustment element, such as a spool tensioner to allow for tensioning ofthe suture lines in situ as described further below

Various combinations of the above elements as well as any of the otheritems mentioned elsewhere in the disclosure can also be made part of asystem or kit.

Anchor Line Assembly

In some embodiments, the anchor could be injection molded, extruded, orcreated using other known techniques. The anchors could also be heattreated to increase the performance of the implanted material byincreasing the strength and decreasing the potential water absorptionduring implantation time. The heat treatment could also be used totailor the durability, or conversely the bioabsorbability of the anchor.

The heat set PET rod 4000 is cut at an angle, such as about 45 degreesto produce two anchors 4010, each about 15 mm in length with one roundedend 4004 and one cut end 4006. A small blade is used to pierce anaperture 4008 that is about 0.065″×0.013″ through the center of theanchor 4010 as shown in FIG. 108. The aperture 4008 could be orientedlengthwise along the long axis of the anchor 4010 as shown, ortransversely or at an angle in other embodiments.

FIGS. 109A-109C depict various embodiments of an anchor 4010. FIG. 109Adepicts an anchor 4010 prior to the hole 4008 being cut through thecenter. FIGS. 109B-C show the anchor 4010 with a hole 4008 through itscenter. FIG. 109B illustrates that the aperture 4008 is a slit orientedlengthwise parallel to the long axis of the anchor 4010. FIG. 109Cillustrates an arcuate-shaped aperture 4008. The anchors mayalternatively have a non-circular cross-section. For example, an anchormay have a tapered design, rectangular cross section, or contain amember that is hinged.

In some embodiments, anchors 4010 such as the ones shown in FIGS. 109D-Ghave a reinforcing component 4005 such as a band, or the anchor 4005could be alternatively have an integrally formed or welded centralportion made of a stronger material and/or larger outside diameter thatcould provide a larger cross-section that could aid in making the anchor4010 stronger at the region of relatively greater stress in order toreduce the risk of fracturing of the anchor 4010. In certainembodiments, there is a benefit to keeping the anchor 4010 smaller onboth ends as the suture (not shown) and anchor 4010 will lie side byside which increases the crossing profile. Additionally, having anoncircular cross section might optimize the anchor line profile. Forexample, the anchor could have a semi circular cross section allowingthe suture to lay in the remaining space, for a smaller overall “round”crossing profile. In the designs shown in FIGS. 109D-G, the suture couldactually be crimped or compressed down inside the hole 4008. If theanchor 4010 is essentially in-line with the suture, it may have thetendency to deploy in parallel with the suture. Placing an acute angledcut at the tip of the anchor, as illustrated in FIG. 109E and incross-section in FIG. 109F, could assist in directing the anchor awayfrom the suture pathway. The orientation of the suture exiting from theanchor is also an important feature in certain embodiments that maydetermine anchor placement. The anchors in FIGS. 109D-G show that thehole may be cut at different angles to aid in directing the angle thatthe suture exits and therefore the path at which the anchor travels intothe tissue with respect to the suture pathway. In many cases,maintaining the anchor more perpendicular to the suture pathway willincrease the load carrying ability. In some embodiments, the aperture4008 has a central axis 4009 that forms an angle 4003 with thelongitudinal axis of the anchor. The angle 4003, in some embodiments,can be about 90 degrees, or between about 10 and 90 degrees, such asbetween about 30 and 60 degrees, or about 45 degrees in someembodiments. FIG. 109G illustrates an embodiment of an anchor 4010 witha relatively longer reinforcing component 4005. In some embodiments, thereinforcing component 4005 has a length that is at least about 5%, 10%,15%, 20%, 25%, 30%, or more of the total length of the anchor 4010.

In one embodiment, the suture component 4014 is comprised of braided PETmaterial, wound into a 16 carrier braid with 28 picks per inch that canbe cut into lengths. Alternatively, the suture component 4014 may alsobe comprised of any other appropriate materials, such as monofilamentPTFE or polypropylene for example.

In one embodiment, the anchor 4010 is inserted into the suture component4014. FIG. 110A illustrates the anchor 4010 prior to its insertion intothe suture component 4014 at the insertion point 4012. The anchor 4010is inserted into the insertion point 4012 rounded end 4004 towards thetail 4016 (lower suture) as shown in FIG. 110B. The anchor 4010 isinserted into the suture 4014 such that the exposed tip 4011 can be usedto pierce through the braid 2 to 4 strands up from the insertion point4012 as shown in FIG. 110C. Next, 1 to 3 strands are separated creatinga gap over the anchor piercing 4008 such that the upper suture 4018 canbe directly inserted as illustrated in FIG. 111. To maintain a smallcrossing profile, the upper suture 4018 is pulled tight through theanchor 4010. This process is used to prevent the anchor 4010 fromsliding with relation to the suture line 4014.

In other embodiments, additional anchors may be placed following thesame procedure from lowest anchor to highest. This forms a maximumcrossing profile of the diameter of the anchor and 3 layers of thediameter of the suture line.

Sling Assembly

In one embodiment, the sling assembly is comprised of wovenpolypropylene tape 4020. In one embodiment, the polypropylene tape 4020has a 0.006 inch warp and 0.004 inch weft and is cut into 35 mm lengths.A heat sealer is used to bond together the strands creating a sling4032.

In one embodiment, a suture 4030 comprised of polyethylene terephthalate(PET), wound into a 16 carrier braid with 28 picks per inch is cut into64 cm lengths. The suture 4030 is woven through the sling 4032 in azig-zag pattern that will allow the sling to act as a strain reliefunder tension and maintain a flat or substantially flat configurationwhen implanted. Each end 4034 of the sling 4032 can be secured to themain suture with a USP 5.0 size 8 carrier braid, 60 picks per inch PETsuture line. This smaller suture line is looped around the centerportion of the sling and the main suture multiple times. It is thenlooped in a fan array from the end of the sling 4032 through the lowerportion of the main suture 4016. This process is repeated again at theopposite end of the sling. FIG. 112 shows the position of the slingassembly between the tail lengths 4016 of the main suture line 4014.

Anchors may be supported from a generally superior location in a varietyof ways. One embodiment uses a sling type mesh that will support anchorlines from each end of the sling. The sling is used to spread the loadof the anchor lines over a large area of tissue preventing the line fromcutting through tissue due to the weight of the tissue pulling on theanchor lines. In some embodiments, a range of mesh slings could be 4 mmwide by 15 mm long to 20 mm wide by 100 mm long, depending on the massto be supported. The sling can be tapered at both ends to ease entry ofthe device through the skin. The sling is positioned in an archedconfiguration that can be convex or concave in some embodiments using acurved needle as described above to create the proper placement. Thearch helps to prevent the sling from folding thus reducing its effectivesurface area. Suture line is woven through the sling from end to end ina sinusoidal path to give greater strength to the suture-slingconnection and to further keep the sling from folding.

Anchors can also be supported superiorly by other anchors insertedupward. This situation creates tension between the two sets of anchorseach keeping tension on the other.

Variations on Anchor Design

Further reduction in crossing profile is possible through use of a twopiece anchor 4040 in which the suture (not shown) is inserted into ahole 4042 in the leading end 4044 and held in place with pins 4046pressed from the first length 4048 through the suture 4012 and intoholes 4050 in the second length 4052 as shown in FIGS. 113A-C from botha lateral and an axial perspective. FIG. 113A shows the whole two pieceanchor 4040 and the locations of the split line and the hole 4042 in therounded, leading end 4044. FIG. 113B shows the first half 4048 of theanchor with the pins 4046 pushed through it. FIG. 113C shows the secondhalf of the anchor with the holes 4046 for receiving the pins.

The suture may also be held in place by creating a dovetail or squarewave type path between the anchor parts. This reduces the crossingprofile by moving the suture 4014 from the outside to the inside of eachanchor. FIG. 114A illustrates one piece of a 2 piece anchor with achannel 4056 for the suture to sit in and protrusions 4058 on the insideof the channel 4056 to lock in the suture 4012. The mating half of theanchor would be complementary to the half shown in FIG. 114A. The anchormay also be over-molded onto a line or wire for a secure hold andreduction in profile in other embodiments.

FIGS. 114B-C depict other embodiments of 2 piece anchors. FIG. 114Bshows a first half of a 2 piece anchor with a trough 4043 that thesuture could be placed into with pins 4045 that will lock the anchorinto the suture. Pins 4045 are added to help align the tip side 4049 ofthe anchor. Another ridge 4047 may be added to the entire length of theanchor which would aid in strength and cohesion of the anchor. FIG. 114Cshows the mating part that is connected to the anchor half shown in FIG.114B to lock in the suture. The two pieces may be connected in a varietyof ways including the mechanical snaps shown in FIGS. 114B-C, oralternatively, for example, press fits, heat, adhesive, ultrasonicwelds, or solvent. FIG. 114D shows the two halves of a 2 piece anchorready to be mated together. FIG. 114E shows a complete 2 piece anchorwith the two pieces mated together.

A benefit of this design is added strength for increased clinicaldurability. The parts may simply be attached, such as by snapping on,and additionally adhered if necessary. The design may not, in someembodiments, have a need for piercing, threading, suturing, or knottying, all of which might degrade the strength of the components. Partsmay be put together manually or in an automated fashion. For example,two feeder bowls that contain the left and right parts, respectively,may be used. The parts may then be aligned and fastened to the suture ina conveyor type system. This may add to increased quality while alsoimproving manufacturing efficiency.

In another embodiment, a 2 part anchor may utilize a suture that has aknot in it. This would add to the mechanical holding ability withoutrelying as much on the protrusions or tabs to pierce through the suture.

A multiple piece anchor may also “scissor” out from the insertion line,or in other words expand radially outwardly, such as via a shape memorysetting or radially outward bias to create a double barb to hold tissueas shown in FIG. 115. In some embodiments, an anchor could have at least2, 3, 4, 5, 6, 7, 8, or more barbs extending radially off a single pointoff the insertion line.

In one embodiment, the anchor is made from a polyester, morespecifically polyethylene terephthalate or PET. Other materials thatcould be used include, among others, polyetheretherketone (PEEK),polyester, nylon or other polymers, metals, and ceramics. Materials,including the anchors, insertion lines, and the sling may be permanentlyimplantable for a long effective life or alternativelybiodegradable/bio-absorbable such that the implant is effectivelyremoved from the tissue in a given amount of time. Materials may becoated to prevent tissue ingrowth onto the anchor or coated with atissue ingrowth material such that tissue will grow into the anchors. Insome embodiments, one or more of the anchors, insertion lines, or slingcould be coated with a drug, for example, an antibiotic.

The surface finish of the anchor may be smooth for ease of delivery ortextured for greater contact area and hold on the tissue. The exposedtip of the anchor may skew out at an angle to assist it in thetransition from 0 to 90° when applying tension. The tip may be forked togain a hold on the tissue and to prevent it from sliding longitudinally.

In one embodiment, screw-type threaded anchors are used. Screw typeanchors may be drilled directly through the skin or delivered to apreferable site via a cannula. In one embodiment, threaded devices mayrange in length from 1 cm to 10 cm, and in diameter from 2 mm to 10 mm.Thread pitch may range from 2 to 20 threads per inch. Longer screwdevices 4064 may be broken into several sections 4066 for flexibilitywith or without linkages to prevent independent rotation as shown inFIG. 116. Anchors may be relatively straight, or curved as shown.

In another embodiment, corkscrew anchors as shown in FIG. 117 are used.A corkscrew anchor having the same dimensional range as the screw typemay result in greater tissue support with less implanted material.Screw/corkscrew anchors can be driven using a tubular driver such thatthe suture line will travel through the driver avoiding windup. Theconnection between the screw head and the driver can be of any formatdesired, such as slotted, Philips, hex, star, or square headed forexample.

A tether line, such as a suture line, connects the various parts of thesystem, for example, connecting a sling to an anchor. Suture materialcan be elastic or inelastic. A non-elastic suture may provide greaterstrength to the support system while an elastic suture may be able togive a more natural elasticity depending on the desired clinical result.

Device Technique

Some embodiments of the system insertion technique are described below.One embodiment is shown in FIGS. 118-119 in which the leading end 4004of each anchor 4010 is contained within the suture line 4014. Thisfeature forces the anchor 4010 to be in the same orientation as thesuture 4014. In this position, the device has its minimum crossingprofile and is able to move smoothly through a cannula and/or tissue inthe direction of insertion as shown in FIG. 118. When tension is appliedto the suture as shown in FIG. 119, the crossing profile increases andthe anchors become embedded within the tissue.

In one embodiment, the device is delivered through a cannula, such as a9.5 French diameter cannula. A long, curved needle sheathed inside acannula is inserted superiorly into the top of the breast tissue andexits inferiorly at the bottom of the breast just below the areola. Theneedle is then removed, leaving the cannula in place creating a pathwayfor the anchor system to be delivered. A flexible feeder rod with aneedle eye at one end is used to pull the lower (inferior) suture linethrough the cannula. Once the lower suture line has exited the lower endof the cannula the feeder rod is removed. At this time the upper(superior) suture line is extending out of the cannula leer and thelower suture line is extending out of the tip of the cannula. By pullingeach line, the anchors can be optimally positioned within the breasttissue. Once the optimal position is obtained, the physician can holdthe lower suture line in place and remove the cannula, thus exposing theanchors to the tissue. The device can be positioned before removing thecannula through the insertion site.

In another embodiment, the device is delivered by threading the anchorlift component directly into the tissue using a sheathless needle. Inthis case, the suture line is fed through the eye of a rigid needlewhich will pull the lower suture line into the upper breast tissue andexit the lower breast. The anchors are pulled into the tissue to thedesired position by pulling on the lower suture line. The device ispositioned using external reference points on the suture line. Ifinitial placement is too high, the device will easily move throughtissue by applying tension to the lower suture line. If initialplacement is too low, the top and bottom suture lines are tied togetherusing the upper line to pull the lower line through the tissue in a fullcircle. Lower suture lines are not a functional requirement of thesystem, although they could be advantageous in some circumstances toprovide ease of placement and facilitate retrieval in the event ofmisplacement. Lift is created when tension is applied to the anchor viathe sling, thus raising the soft tissue.

When securing the device in place, tension is applied to the uppersuture line which causes pressure to be applied to the angled surface onthe exposed tips of the anchors which causes the anchors to rotate outand engage the tissue.

Small Profile Device

In one embodiment, a small profile device such as illustrated in FIG.120 is provided. By reducing the profile 4013 of the device, smalleropenings are required in the tissue. Smaller openings reduce the amountof scarring, pain, and trauma while increasing ease of delivery. In oneembodiment, the anchor diameter measures about 0.02 to 0.09 inches, suchas about 0.07 inches. The anchor length could range from about 0.5 to2.0 cm, such as about 1.5 cm in length in some embodiments. Therelatively small diameter of the anchor with respect to the suture is anadvantageous aspect in this device as a large insertion hole created toplace this device below the skin surface could cause scarring due to theentry hole. Reducing the crossing profile of the device would also helpreduce the amount of pain and tissue trauma, while increasing ease andefficiency of delivery.

Another advantageous feature of the embodiment is the ratio of thelength of the anchor to the diameter and exposed portion of the suture.This aspect ratio, which can be defined as the surface area of thetransverse anchor with respect to the combined cross-sectional diameterof the anchor and the suture, would be rather small if the suturemeasured about 0.03 inches and the anchor measured about 0.06 incheswhere the ratio would be 2:1. In this embodiment, the aspect ratio couldbe between about 6:1 and 10:1, such as between about 7:1 or 9:1, orabout 8.5:1 in some embodiments as the anchor is allowed to tilt outwardfrom the central axis allowing additional tissue engagement. Thisfeature could have additional benefits given the plurality of tissueanchors attached to each suture, such as at least 2, 3, 4, 5, 6, 7, 8,9, 10, 11, 12, 13, 14, 15 anchors, or more in some embodiments.

When securing the device in place, tension is applied to the uppersuture line 4018, applying pressure to the angled surface 4017 on theexposed tips of the anchors as shown in FIG. 121. This pressure causesthe anchors to rotate from the line pathway) (0°) to a maximum angleperpendicular to the suture line 4018 to a maximum of 90 degrees asshown in FIG. 122. The large aspect ratio creates more surface area todisperse the load onto more tissue.

Anchor design that allows for direct insertion (without a cannula orsheath) would also aid in decreasing the system profile. For directinsertion, the device should, in some embodiments, not only have a smalldelivery profile, but also have a smooth finish and gradual transitions.This embodiment of the device and attachment method allows for both. Asystem size of 9.6 F can be reduced down to 7 F or less without the useof a cannula or sheath.

Optimal Tissue Pathway

In inserting the upper portion of the device, it can be desirable tocreate a pathway with great holding and tissue supporting ability. Oneway to create this pathway is to use the upper needle design thatcreates a path beneath the skin that has a high arch aspect ratio inrelationship to the distance between the entry points 4070. For example,if the entry points are 7.5 cm apart, the arch pathway could be 1 to 2cm higher in a 270 degree needle, versus a 180 degree needle. In thisexample, the 270 degree needle would have a curvature radius of 7.5 cm,while the 180 degree needle would have a curvature radius of about 10cm. Since of the needle needs to be exposed for the user to push andpull, the 270 degree allows for the optimal semi-circular path under theskin, while having needle exposed to hold. This higher tissue path arch4072, such as an arch of greater than about 180 degrees, or about 270degrees helps hold more tissue and begins to create a more verticalcomponent to the sling rather than a flatter arc 4074 that will migrateinto a smaller radius curve under loading. In some embodiments, as notedabove the arc formed could be between about 120 and 330 degrees, betweenabout 180 and 270 degrees, or at least about 150, 165, 180, 195, 210,225, 240, 255, 270, 285, or 300 degrees in some embodiments. A verticalpath 4076 at the endpoints helps prevent a sharp angle from the sling toanchor lines which could result in cheese wire cut (more focal stress).This extra distance 4078 as shown in FIG. 123 will help maintain theinitial position of the lifted or suspended tissue. It has beendemonstrated clinically that the tissue tends to pull the upper slingfrom a flat implanted position to a more arched shape under loading. Insome embodiments, the sling forms an arc of, for example, of betweenabout 120 and 330 degrees, between about 180 and 270 degrees, or atleast about 150, 165, 180, 195, 210, 225, 240, 255, 270, 285, or 300degrees in some embodiments, but less than about 360 degrees.

Minimize Acute Lift Loss

To minimize acute lift loss, a mechanism for quickly securing andpreventing slippage of the suture material is desired rather thanconventional surgeons' knots for attachment of the suture. It isdifficult to tie knots external to the skin surface and push them belowthe skin surface without losing some tension or lift due to theextension of the sling outside the skin. The disclosure here discusses amechanism for placing the two suture lines under the skin duringtensioning so there is very limited loss of tension during the sutureconnection.

Another embodiment of the support device is a method to tension andsecure the components without the use of knots. Knots have been known toslip and are difficult to throw under the skin surface, depending on thesuture material and the type of knot used. Knots with suture sometimesrequire several throws and can be time consuming. Also, if a knot istied outside the skin, some tension may be lost as the knot is pusheddown into the tissue. For these reasons, a device to secure the sutureswith respect to each other at the site of implantation is beneficial.

The device placement of the mesh sling line and the anchor lines can beperformed using the same percutaneous approach as described earlier. Thecomponents described here allow for quick adjustment at initialimplantation and could also be readjusted at a later date.

The sling 4032 and anchor lines 4082 are first inserted using apercutaneous approach to the desired locations as shown in FIG. 124A.The upper suture tails 4094 are then lifted and the medial and lateralsuture ends secured using releasable clamps 4084 as shown schematicallyin FIG. 124B. The retainer 4086 is then placed over suture lines 4094and pushed down into the tissue using the retainer push tube 4088 asshown in FIGS. 124C-D. While the suture lines 4094 are being tensioned,the wedge push rod 4090 is used to deliver the wedge 4092 down throughthe retainer push tube 4088 and into the retainer 4086 to lock thesutures into place as shown in FIGS. 124E-G. The wedge push rod 4090 andretainer push tube 4088 are then removed, leaving the wedge 4092 lockedinto the retainer 4086 as shown in FIG. 124H.

In one embodiment, the retainer is made of an implantable polymer suchas polyethylene terephthalate or PET. Alternatively, the retainer couldbe made from other materials including, among others,polyetheretherketone (PEEK), polyester, nylon or other polymers, metals,and ceramics. The dimensions of the retainer may range from about 1 toabout 10 mm in outer diameter and a length of about 1 to about 10 mm.Preferably, the retainer has an outer diameter of about 3 mm, a lengthof about 5 mm, and an inner diameter of about 1.75 mm. The retainer maybe a straight tube, or of noncircular design, or of a tapered shape. Theretainer shown in FIG. 124I has a tapered inner diameter. This will matewith the wedge shown in FIG. 124J and have increased locking abilitywith increased tension.

The retainer push tube (RPT) mates with the retainer to push down overthe suture lines. The RPT may be made of polymers providing a relativelyrigid sheath material such as nylon, pebax, Teflon, PEEK, or polyimide.It may also be made of a metal. The dimensions of the RPT could bearound 1.5 mm to about 12 mm in outer diameter and about 1 to about 20cm in length. In some embodiments, the RPT would have an outer diameterof about 3.5 mm, a length of about 50 mm, and an inner diameter of about2.5 mm. The distal end could have an inset shelf or counter bore with adiameter of about 3.1 mm and a length of at least 1 mm to hold theretainer. The RPT could be press fit with the retainer. Alternatively,the RPT could have an active means of locking, unlocking, and relockingif necessary for future adjustment. The tip of the RPT should have atapered transition to allow for less traumatic delivery. The back end ofthe RPT could have a handle, luer connecter, or other feature to helphold, push, torque, or steer the retainer to the desired location. Ifthe RPT has an active lock/engagement, this could be located as atab/knob activation on this back end handle.

The wedge is designed to fit inside the retainer and capture the suturesin place between the wedge and retainer. The wedge may be made of animplantable polymer such as polyethylene terephthalate (PET).Alternatively, the wedge could be made from other materials including,among others, polyetheretherketone (PEEK), polyester, nylon or otherpolymers, metals, and ceramics. The back end of the wedge has aconnection feature to lock into the wedge push rod. The wedge may betapered, barbed, grooved, or have some other locking feature to provideadditional locking ability. In one embodiment, the wedge has barbs thatlock in the suture and increase their hold when the wedge is pushedfarther into the retainer.

The dimensions of the wedge may comprise an outer diameter of about 1 to10 mm and a length of about 1 to 10 mm. Preferably, the dimensionscomprise a diameter of about 1.5 mm at the tip to 2.4 mm over a 5 mmlength.

An embodiment of a round, tapered wedge is shown in FIG. 124J. The wedgemay come in a variety of geometries such as, e.g., straight, tapered,round, rectangular, oval, or tubular.

The wedge push rod (WPR) is designed to deliver the wedge. It may bemade of a relatively rigid material such as steel or certain polymers.In one embodiment, the WPR is made of solid stainless steel with a firstenlarged diameter and a second reduced diameter at the tip to mate withthe wedge. The rod could have a diameter of about 0.5 to 5 mm, but morepreferably around 1 mm. The mating tip of the rod could then be reducedfrom the rod diameter to about 0.75 mm in this example. The length ofthe reduced diameter could be around 0.1 mm to 10 mm, but morepreferably about 1.5 mm in some embodiments. The device has a releasablemating feature to deliver the wedge, but then releases once the wedge isin place. The WPR could be press fit with the wedge. Alternatively, theWPR may have active means of locking, unlocking, and relocking ifnecessary for future adjustment. The back end of the WPR could have ahandle, luer connector, or other feature to help hold, push, torque, orsteer the wedge to the desired location. If the WPR has an active lockor engagement, it could be located as a tab or knob activation on theback end handle.

Spool Tensioner

The spool tensioner is another component that allows for tensioning ofthe suture lines in situ. This system may be used during theimplantation procedure of the sling and anchor system. This system mayalso be used post-procedurally at any time after the initial procedureto create additional tension, and lift. This system may also be used inother applications involving tensioning of sutures, wires, strands, andother flexible components.

FIG. 125A shows one example of a delivery system including: the deliveryshaft 4089, the cap delivery tube 4091, and the tensioning driver 4093.A suture line 4095 is also shown in this figure. The spool 4097 andspool cap 4087 are shown embedded in the delivery shaft 4089, as shownin the more detailed cut-away view of FIG. 125B. The delivery shaft4089, cap delivery tube 4091, and the tension driver 4093 can all becoaxial as shown in the FIG. 125A, but other embodiments may beconfigured non-coaxially. In non-coaxial embodiments, the delivery toolsmay be hollow or solid.

In one embodiment, the delivery shaft is made of a small diameter tubemade of a rigid polymer or metal. The distal tip may have a pointed orcone shaped end to help pierce and deliver through skin and tissue. Theback end may have an enlarged or textured region that creates a handleto help steer, torque, and push the system. The diameter of the shaft isin the range of about 1 to 10 mm in diameter, but more preferably 3 mmand about 2 to 20 cm in length, but more preferably 5 cm.

In one embodiment, the cap delivery tube is made of a small diametertube made of a rigid polymer or metal. The distal tip may have a lockingmechanism to deliver the cap. Pins that extend past the distal tip ofthe cap delivery tube can also be present that will mate with 2 holes inthe cap. This allows for torque and push, but will release whenretracted with enough force. The back end may have an enlarged ortextured region that creates a handle to help steer, torque and push thesystem. The diameter of the shaft could in some embodiments be in therange of about 1 mm to about 10 mm, such as about 2.8 mm. The shaftlength could be in the range of about 2 to about 25 cm, such as about 7cm.

In one embodiment, the tension driver is made of a small diameter tubemade of a rigid polymer or metal. The distal tip may have a twistingmechanism like that of a screw driver or Allen wrench. FIG. 125B showsthe head of a flat screwdriver 4103 on the distal end that extends tomate with the slot of the spool 4097. This allows the ability to torqueor twist the spool 4097 to wind up the suture, but will release whenretracted. The back end may have an enlarged or textured region thatcreates a handle to help steer, torque and push the system. The diameterof the shaft is in the range of about 0.1 to 5 mm, such as about 1 mm,and in the embodiment shown fits through the cap and cap delivery tube.The shaft length could in some embodiments be in the range of about 2 cmto about 30 cm, but more preferably about 9 cm. FIG. 125B also shows thespool 4097 and cap 4099 seated inside the delivery shaft window 4107.

FIG. 125C depicts how the delivery shaft and the spool function as ahook. The suture 4095 falls into the window 4107 of the delivery shaftand rides along the edge of the window until it catches in the slot 4105of the spool 4097. The spool 4097 is then wound by extending the tensiondriver 4093 forward and twisting until the desired amount of suture iswound, therefore shortening and tensioning the suture 4095.

After the spool 4097 is wound the desired amount, the cap 4099 isadvanced forward to lock the suture 4095 wound around the spool as shownin FIG. 125D. The cap 4099 is pushed forward using the cap deliverytube. In one embodiment, there are keys in the cap that lock into thekeyways in the spool to prevent them from spinning in relation to eachother. In the embodiment shown, the cap 4099 has a through slot 4109that allows the suture to pass through. Other embodiments may havemultiple slots, such as at least 2, 3, 4, or more slots, a single slot,or no slot at all.

The tension driver and cap tube are then retracted. The spool, cap andsuture are then disengaged from the delivery shaft window. The remainingimplant device is the spool 4097, the spool cap, 4087, and the suture4095 as shown in FIG. 125E.

Post-Procedural Adjustment

The purpose of post-procedural adjustment is to adjust a previouslyimplanted system which would entail locating the point of attachment,adjusting the tension and re-securing the suture. The capability foradjustment after the procedure has been completed would also allow foran adjustment to correct any irregularities during the initialinstallation. Furthermore, after the initial tissue has settled due togravity, an additional lift or adjustment may be desired.

Tools to locate an existing device can be used begin the process ofretensioning. A simple tool to capture the suture or implant couldinclude a small hook to be placed under the skin and maneuvered tolocate the suture material for tension and knotting or securing. Oneembodiment of the hook is shown in FIGS. 126A-D. It could be made of ametal such as stainless steel, with a diameter of about 1 mm and a hook4098 that could be J-shaped formed into the end in some embodiments. TheJ-shaped hook could be configured such that it has a radius of curvature4100 and flat sides 4102 such that the diameter of the hook is less thanthe diameter of the round shaft of the hook body 4104. This allowssuture to be located on both sides of the hook and still give the hookportion 4098 a smaller cross-section than the round shaft of the hookbody 4104. This allows the hook 4098 and suture to pass through a smalldiameter securement component.

Location of these sutures may be difficult, so additional tools may beneeded to locate the lines externally, from above the skin. Radiopaquemarkers may be placed on the implant to allow imaging modalities such asX-ray, fluoroscopy or ultrasound to be used. CT or MRI imaging couldalso be used, but would delay the physician due to processing timesassociated with those technologies. The simplest technique may be acombination of internal hooks or tools in combination with thephysician's tactile feel for the device on the surface of the skinduring the suture exploration. In some embodiments, the markers may bemagnetic to facilitate locating the implant.

Beads or other radially enlarged elements may also be attached to thesuture ends to help locate them. Additionally, visual tools such asendoscopes or integrated fiber optics may help locate the suture throughsmall port access in the skin. Polymer, metal, or ceramic beads could beadded onto the suture by methods including mechanically tying, crimping,adhesive bonds, and over-molding. The beads may be located by methodssuch as fluoroscopy or tactile feel.

The adjustment may be accomplished by tensioning the suspension linesfarther or shortening the length between the anchors. In one embodimentof the device, anchors are suspended from the sling where the sling issuperior to the anchors and the anchors are engaged in soft tissue. Thedistance from the superior sling to the anchors may be shortened, thusincreasing the tension and lifting the soft tissue further. Thisshortening technique may be accomplished by a simple knotting whereexcess suture is taken up through the knot and the section between thesling and anchors is reduced in length.

Additional techniques in suture shortening include winding, looping,coiling, or other means to reduce the length and add tension or lift theassociated tissue. In some embodiments, an adjustment element such as alockable spool could be present along an anchoring line that could beadjusted without the need for detaching and reattaching a portion of theanchor line. One additional method to shorten the suture would be toloop 4140 the suture material through a tubular member 4142 and traversethe loop 4140 back around the tube, securing it upon itself and lockingit into position as shown in FIGS. 127A-D. For this technique, a taperededge would be advantageous to keep the suture from slipping off the endand disengaging from the tubular portion. The tubular portion may beconstructed from an elastic material to accommodate variations inloading conditions acting as an energy absorption component. Thistranslates a linear tension force into a compression force and allowsfor better fatigue resistance. The tubular material may be of a softdurometer material such as silicone or any biocompatible urethanematerial. The tubular portion has dimensions to allow passage of thesuture material through the inner diameter and a wall thickness tomaintain structural integrity throughout the life of the implant. Insome embodiments, dimensions could include an inner diameter of about0.05 inches and an outer diameter of about 0.090 inches and a lengthranging from about 0.2 inches to about 0.5 inches depending upon thelift or shortening desired.

An alternative adjustment technique is accomplished by using a hook typedevice 4162 to find the suture line 4164. Once the suture line 4164 isfound, the method for the acute lift loss previously described may beused to secure the device as shown in FIGS. 128A-D. The Retainer 4086would first be placed over the suture lines and pushed down into thetissue using the retainer push tube. While tensioning the suture lines4164, the wedge push rod is used to deliver the wedge 4092 down throughthe retainer push tube and into the retainer 4086 to lock the sutures inplace. The retainer push tube and wedge push rod are then removed. Thematerial 4163 that is captured by the wedge-retainer creates tension andshortening between the sling 4032 and anchors 4010. One or both sidesmay be adjusted.

Variable Product Life Span

Sling materials may include, for example, flat, oval, or roundpolypropylene materials woven or braided into an open architecture fortissue in-growth. ePTFE or another porous material may be used in someembodiments. Other materials that may be used include cross-linkedtissue such as bovine, equine or porcine tissues, xenografts, orallografts that the surrounding tissue would recognize as inert. Otherbiological tissues such as collagen or small intestinal submucosa couldalso be used. These and other materials could be fixed or designed tomaintain their inert properties or promote ingrowth. They may also bedesigned to erode, allowing the surrounding tissue to absorb the implantover a defined period. The advantage of arcuate such as roundconstruction is that there is no preferential axis to cut into thetissue under loading. Flat materials would be the smallest constructionand allow the smallest entry hole through the skin. Folding forinstallation and flattening after installation would allow the materialto be installed with a small profile and perform open, displaying thelargest surface area possible. This function of small entry is helpfulin reducing the scars the patient may receive from the deviceinstallation.

Device materials and procedures for implanting the device may be variedaccording to the life span goals of the device. Durable materials couldbe used for a device to remain implanted in the body for at least 1, 2,3, 4, 5, 6, 7, 8, 9, 10, or more years. In some cases, a shorter devicelife span, such as 5 years, 1 year, or even less may be desirable forthe patient who wants short term benefits. This may be due to thepatient's anatomy, additional sagging, life activities, and bodystructure among other things that cause the patient to no longer wantthe device effective or even present. This phenomenon is observed asmany gel/saline implants are removed as a patient's desire or agechanges.

Durable materials may be metals, polymers, or ceramics. More specificexamples are PEEK, PET, Nylon, stainless steel, nitinol, and cobaltchromium among others.

Absorbable materials include poly(alpha-hydroxy acid) such aspoly-L-lactide (PLLA); poly-D-lactide (PDLA), polyglycolide (PGA),polydioxanone, polycaprolactone, polygluconate, polylacticacid-polyethylene oxide copolymers, modified cellulose, collagen,poly(hydroxybutyrate), polyanhydride, polyphosphoester,poly(amino-acids), or related copolymers materials, PET, ceramic, andhydroxyapatite among others. Many polymers can be processed to changemechanical integrity or absorbability. Materials and designs ofcomponents may be selected to result in devices with a predeterminedlife span or including a certain safety value, like containing a shearpin.

Mechanical characteristics may be created for more complex materials byhaving a composite or reinforced part to add rigidity and strength whereneeded and flexible and soft materials in other places. For example,greater strength could be achieved with metal ribs placed in theattachment area, such as at the hole location, with the rest of thedevice made from a polymer. The product may be insert molded. Short termfastening features like barbs or hooks may be made from bioabsorbablematerial.

Anchor to Anchor Suture Lines

One embodiment of the device includes a sling portion made entirely ofsuture, without any mesh. This device may then be implanted through asingle pathway and at any location. Varying lengths, diameters,materials and number of barbs may be used.

Enhanced Suspension Elements

With enhanced suspension elements in the system, the device may achievebetter compliance and a better look and feel. In one embodiment,enhanced suspension is achieved by adding springs along the suture line.The springs may be made of metal. A variety of springs may be usedincluding coil springs, leaf springs, torque springs, and wave springs.In another embodiment, pressurized air cylinders may be used in linewith the sutures to achieve enhanced suspension. Alternatively, anelastomeric material may be inserted inside the suture braid to enhancesuspension. The elastomeric material may also be inserted in a cylindertype design so that it is in compression, increasing its suspensioncapabilities.

Device Used to Suspend or Position Gel or Saline Implants in Tissue

Common breast implants are placed beneath or above the pectoral muscle.Pockets are often created to house or locate the implant in a definedposition, but due to activity, the implants often shift or move fromtheir desired location. This movement may also be caused bygravitational forces over time. If an additional component such as oneof the suspension devices disclosed above were attached to the implant,the implant may have a lower tendency to droop or bottom out. The suturelines may be attached to the implant by means of tabs or attachmentpoints to the implant where a plurality of sutures hold the relativeposition of the implant with respect to the upper sling. In oneembodiment, the implants are manufactured so that the tabs or otherconnection devices are integrated into current implants. Alternatively,tabs may be attached to pockets, retainers, meshes, bags, harnesses orthe like to aid us using the system with off the shelf items. Eachimplant may be attached using one, two, or more tabs. The tabs may beconnected at the bottom or top of the implant or both. The tabs may beof various lengths. Additionally, the tabs may be rigid or elastic toabsorb any shock loading of the suture lines attached. The tabs may beattached to sling type anchors or barbed type anchors, several of whichare described elsewhere in the application, or sutured directly to oraround tissue or bone. Other soft tissue implants other than breastimplants, such as gluteal, lip, nasolabial fold, cheek, etc. implantscan also be suspended as disclosed herein. FIGS. 129A-D depict variousimplants 4166. FIG. 129A illustrates an embodiment of an implant 4166with superior tabs 4168 with apertures or other attachment means forconnection to a superior support sling 4170 that can be as previouslydescribed. FIG. 129B illustrates an implant 4166 with both superior andinferior tabs 4168 suspended superiorly using sling 4170 as noted above.The implant 4166 is attached via the inferior tabs 4168 to suspensionlines 4172, which may include anchors that may be in the form of barbsas shown. In some embodiments, the implant 4166 could be suspended by atleast 1, 2, 3, 4, 5, or more superior and/or inferior anchor suspensionlines. FIG. 129C illustrates an implant 4166 suspended by multiplesuperior 4174 and inferior anchor suspension lines 4168 spaced about 120degrees apart. The anchor suspension lines could be spaced unequallyapart in other embodiments. FIG. 129D illustrates an implant 4166 insideof an enclosure 4176 which could be an open structure such as a weave asshown or a closed structure more akin to a handbag. Implant 4166 can besupported superiorly by a sling 4170 as previously described. Anycombination of other elements described to support an implant such astabs, an enclosure, etc. can be used with any of the described aboveembodiments to fix the implant to tissue or bone, for example withsutures. The implants shown may be filled with saline, silicone, orother substances depending on the desired clinical result. In someembodiments, the implants can be as described, for example, in U.S. Pat.No. 3,852,832 or 6,913,626 to McGhan or U.S. Pat. No. 5,525,275 or5,964,803 to Iversen et al., which are all incorporated by reference intheir entireties. In some embodiments, another element may suspend frombeneath the implant with additional sling(s) to hold the relativeposition with respect to the upper sling.

Removal Tools

After implantation, the device may be removed by means of locating andcoring tools to release the device from the surrounding tissue. Oncelocated, the suture or implant could be held relative to a coring toolto cut the surrounding tissue by advancement around the suture material.This allows a section of tissue and the implant to be separated from thepatient with little trauma or bleeding. By separating the device intomultiple components, it aids in the removal process due to the reductionin component length and complexity of the implant pathway. The coringtool may be a simple hypo tube made from stainless steel or Nitinolwhere the distal tip is sharpened to provide a cutting means. The tubemay also be constructed of a flexible proximal section and a more rigiddistal section where flexibility allows articulation about the device.Additional means for removal include a rotational tool to twist theimplant from the surrounding tissue and release any tissue attachment.The device may then be pulled from the patient with little force andtrauma. This method requires a locational tool to find the suture and anattachment of the tool to the suture for rotational forces to twist theimplant from the surrounding tissue.

Additional Areas where Soft Tissue Lift and Suspension would be Desired

Additional areas possibly requiring soft tissue lift and suspensioninclude the buttocks, thighs, abdomen, and facial areas, such as, forexample, eyelids, eyebrows, forehead wrinkles, nasolabial folds, chin,facial droop caused by temporary or permanent paralysis such as Bell'spalsy or a stroke, or other locations where the scale of the deviceneeds to be adjusted for the associated anatomy and surroundingattachment points. An example is a device used in the buttocks that isscaled up in size and has an increased anchoring area or is fixed to abone structure. Another example is a device in the facial where the sizeis culled down for less support and a thinner tissue and fat layer to besupported.

Although preferred embodiments of the disclosure have been described indetail, certain variations and modifications will be apparent to thoseskilled in the art, including embodiments that do not provide all thefeatures and benefits described herein. It will be understood by thoseskilled in the art that the present disclosure extends beyond thespecifically disclosed embodiments to other alternative or additionalembodiments and/or uses and obvious modifications and equivalentsthereof. In addition, while a number of variations have been shown anddescribed in varying detail, other modifications, which are within thescope of the present disclosure, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or subcombinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the present disclosure. Accordingly, it should be understoodthat various features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the present disclosure. Thus, it is intended that the scope ofthe present disclosure herein disclosed should not be limited by theparticular disclosed embodiments described above.

1. A method of performing a breast tissue lift, comprising the steps of:introducing an elongate, flexible mesh sling, having a first end and asecond end, subcutaneously along a generally medial-lateral axis above abreast; introducing a first suspension line along a first generallyinferior-superior axis, the first suspension line carrying a firstinferior soft tissue anchor and having a first superior free end;introducing a second suspension line along a second generallyinferior-superior axis, the second suspension line carrying a secondinferior soft tissue anchor and having a second superior free end;connecting the first superior free end to the first end of the sling;and connecting the second superior free end to the second end of thesling.
 2. The method of claim 1, wherein introducing the elongateflexible sling comprises inserting the first end of the sling along witha needle through a superior port accessing the subcutaneous tissue, andadvancing the first end of the sling laterally while in the subcutaneoustissue.
 3. The method of claim 2, wherein introducing the elongateflexible sling comprises inserting the second end of the sling alongwith the needle through the superior port accessing the subcutaneoustissue, and advancing the second end of the sling medially while in thesubcutaneous tissue.
 4. The method of claim 3, further comprisingapplying traction on the first end of the sling and the second end ofthe sling such that the sling is fully pulled through the superior portand into the subcutaneous tissue.
 5. The method of claim 1, whereinintroducing the first suspension line comprises advancing a cannulahousing the first suspension line subcutaneously to an exit point at thebase of the breast.
 6. The method of claim 1, wherein connecting thefirst superior free end to the first end of the sling comprises tying aknot.
 7. The method of claim 1, further comprising the step ofintroducing a third suspension line along a third generallyinferior-superior axis, the third suspension line carrying a thirdinferior soft tissue anchor and having a third superior free end; andconnecting the third superior free end to the first or second end of thesling.
 8. The method of claim 1, wherein the suspension line comprisesone of the group consisting of: a suture, a wire, and a spring.
 9. Themethod of claim 1, wherein the first suspension line carries at leasttwo soft tissue anchors.
 10. The method of claim 1, wherein the firstsuspension line carries at least four soft tissue anchors.